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1
Inheritance
4
Pathophys.
7
Phenotypes
17
Pathograph
7
Genes
4
Treatments
3
Subtypes
3
Trials
6
References
1
Deep Research
👪

Inheritance

1
Autosomal recessive HP:0000007
ARCI is caused by biallelic pathogenic variants in multiple causative genes.
Autosomal recessive inheritance
Show evidence (1 reference)
PMID:36980989 SUPPORT Human Clinical
"ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
Directly supports autosomal recessive inheritance through biallelic pathogenic variants.

Subtypes

3
Lamellar Ichthyosis MONDO:0017778
67.5% in a 74-patient Italian ARCI cohort
Major ARCI phenotype with generalized large scales, typically less prominent erythroderma, and variable ectropion or palmoplantar involvement.
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"RESULTS: Seventy-four consecutive patients (mean age 11.0 years, range 0.1-48.8) affected with lamellar ichthyosis (50/74, 67.5%), congenital ichthyosiform erythroderma (18/74, 24.3%), harlequin ichthyosis (two/74, 2.7%), and other minor ARCI subtypes (four/74, 5.4%) were enrolled."
Supports lamellar ichthyosis as the largest major subtype in this genetically confirmed ARCI cohort.
Congenital Ichthyosiform Erythroderma MONDO:0019306
24.3% in a 74-patient Italian ARCI cohort
Major ARCI phenotype characterized by generalized scaling with more conspicuous erythroderma than classic lamellar ichthyosis.
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"RESULTS: Seventy-four consecutive patients (mean age 11.0 years, range 0.1-48.8) affected with lamellar ichthyosis (50/74, 67.5%), congenital ichthyosiform erythroderma (18/74, 24.3%), harlequin ichthyosis (two/74, 2.7%), and other minor ARCI subtypes (four/74, 5.4%) were enrolled."
Supports congenital ichthyosiform erythroderma as a major ARCI subtype in a genetically confirmed cohort.
Harlequin Ichthyosis MONDO:0009443
2.7% in a 74-patient Italian ARCI cohort
Severe ARCI phenotype, most often linked to ABCA12 loss-of-function, with profound neonatal hyperkeratosis and barrier compromise.
Show evidence (1 reference)
PMID:36980989 SUPPORT Human Clinical
"The most severe form of ARCI, harlequin ichthyosis, is caused by mutations in ABCA12."
Supports harlequin ichthyosis as the severe ABCA12-associated ARCI phenotype.

Pathophysiology

4
Biallelic ARCI Gene Defects
ARCI begins with biallelic pathogenic variants in a heterogeneous set of genes involved in epidermal cornification, lipid transport, and lipid metabolism.
keratinocyte link
TGM1 link ABCA12 link ALOX12B link ALOXE3 link CYP4F22 link NIPAL4 link CERS3 link PNPLA1 link SDR9C7 link SULT2B1 link
keratinization link ⚠ ABNORMAL lipid metabolic process link ⚠ ABNORMAL
skin epidermis link
Show evidence (1 reference)
PMID:36980989 SUPPORT Human Clinical
"ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
Directly supports the core biallelic ARCI gene spectrum.
Cornified Envelope Cross-Linking Defect
TGM1-associated ARCI disrupts transglutaminase-dependent cornified-envelope formation in differentiating keratinocytes; this mechanism is associated with higher severity and thick brownish scales in cohort data.
keratinocyte link
TGM1 link
epidermal cell differentiation link ⚠ ABNORMAL
skin epidermis link
Show evidence (2 references)
PMID:38588653 SUPPORT Human Clinical
"The mean ichthyosis severity score in TGM1- and ABCA12-mutated patients was significantly higher than in all other mutated genes, while the lowest score was observed in CYP4F22-mutated patients."
Supports TGM1 as a high-severity ARCI genotype.
PMID:38588653 SUPPORT Human Clinical
"Ultrastructural data available for 56 patients showed a 100% specificity of cholesterol clefts for TGM1-mutated cases and revealed abnormal lamellar bodies in SDR9C7 and CERS3 patients."
Supports a genotype-informative ultrastructural abnormality in TGM1-associated ARCI.
Epidermal Lipid Processing and Transport Defect
Multiple ARCI genes affect epidermal lipid metabolism, lipid transport, or acylceramide-related barrier biology. ABCA12-associated ARCI is especially severe when both alleles cause loss of function.
keratinocyte link
ABCA12 link ALOX12B link ALOXE3 link CYP4F22 link NIPAL4 link CERS3 link PNPLA1 link SDR9C7 link SULT2B1 link
lipid transport link ⚠ ABNORMAL ceramide biosynthetic process link ⚠ ABNORMAL establishment of skin barrier link ⚠ ABNORMAL
skin epidermis link
Show evidence (2 references)
PMID:36980989 SUPPORT Human Clinical
"Loss-of-function mutations on both alleles generally result in harlequin ichthyosis, whereas biallelic missense mutations mainly lead to CIE or LI."
Supports ABCA12 functional severity as a determinant of the ARCI phenotype.
PMID:38588653 SUPPORT Human Clinical
"Ultrastructural data available for 56 patients showed a 100% specificity of cholesterol clefts for TGM1-mutated cases and revealed abnormal lamellar bodies in SDR9C7 and CERS3 patients."
Supports lamellar-body abnormalities in lipid-barrier ARCI genotypes.
Abnormal Stratum Corneum and Barrier Phenotype
Defective cornification and lipid-barrier biology converge on abnormal stratum corneum structure, generalized scaling, variable erythema, and chronic skin symptoms.
keratinocyte link
keratinization link ⚠ ABNORMAL epidermis development link ⚠ ABNORMAL
skin epidermis link
Show evidence (1 reference)
PMID:38027029 SUPPORT Human Clinical
"Autosomal recessive congenital ichthyoses (ARCI) are a skin pathology due to genetic causes characterized by a variable degree of desquamation, accompanied by erythema."
Supports the clinical consequence of abnormal scaling and erythema arising from genetic skin-barrier disease.

Pathograph

Use the checkboxes to hide or show graph categories. Hover nodes for evidence and cross-linked metadata.
Pathograph: causal mechanism network for Autosomal Recessive Congenital Ichthyosis Interactive directed graph showing how pathophysiology mechanisms, phenotypes, genetic factors and variants, experimental models, environmental triggers, and treatments relate through causal and linked edges.

Phenotypes

7
Immune 1
Erythroderma Variable Erythroderma (HP:0001019)
Show evidence (1 reference)
PMID:38027029 SUPPORT Human Clinical
"Autosomal recessive congenital ichthyoses (ARCI) are a skin pathology due to genetic causes characterized by a variable degree of desquamation, accompanied by erythema."
Supports erythema as a variable clinical feature accompanying desquamation in ARCI.
Integument 4
Abnormal skin scaling Very frequent Ichthyosis (HP:0008064)
Show evidence (1 reference)
PMID:36980989 SUPPORT Human Clinical
"Autosomal recessive congenital ichthyosis (ARCI) is a non-syndromic congenital disorder of cornification characterized by abnormal scaling of the skin."
Directly supports abnormal skin scaling as a defining ARCI manifestation.
Hyperkeratosis Variable Hyperkeratosis (HP:0000962)
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
Supports thick scaling, particularly in TGM1-associated ARCI.
Alopecia Genotype-associated Alopecia (HP:0001596)
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
Supports alopecia as a genotype-associated ARCI feature.
Pruritus and quality-of-life burden Variable Pruritus (HP:0000989)
Show evidence (1 reference)
PMID:38027029 PARTIAL Human Clinical
"The degree of symptoms is variable, different altered genes are involved, and the symptoms drastically affect patients' quality of life."
Supports clinically important symptom burden but does not quantify pruritus specifically.
Other 2
Ectropion Genotype-associated Ectropion (HP:0000656)
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
Supports ectropion as a genotype-associated clinical sign in ARCI.
Eclabium Genotype-associated
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
Supports eclabium as a genotype-associated ARCI feature.
🧬

Genetic Associations

7
TGM1 (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
Supports TGM1 as a common causative ARCI gene in the cohort.
ALOX12B (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
Supports ALOX12B as a common causative ARCI gene in the cohort.
CYP4F22 (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"The mean ichthyosis severity score in TGM1- and ABCA12-mutated patients was significantly higher than in all other mutated genes, while the lowest score was observed in CYP4F22-mutated patients."
Supports a lower-severity CYP4F22-associated ARCI pattern in this cohort.
ABCA12 (Causative)
Autosomal recessive
Show evidence (2 references)
PMID:36980989 SUPPORT Human Clinical
"The most severe form of ARCI, harlequin ichthyosis, is caused by mutations in ABCA12."
Supports ABCA12 as the gene classically associated with harlequin ichthyosis.
PMID:36980989 SUPPORT Human Clinical
"Loss-of-function mutations on both alleles generally result in harlequin ichthyosis, whereas biallelic missense mutations mainly lead to CIE or LI."
Supports variant-class correlation for ABCA12-associated ARCI phenotypes.
ALOXE3 (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
Supports ALOXE3 as a causative ARCI gene in the cohort.
NIPAL4 (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:38588653 SUPPORT Human Clinical
"Among specific phenotypic features, psoriasis-like lesions as well as a trunk reticulate scale pattern and striated keratoderma were present in NIPAL4-mutated patients."
Supports distinctive NIPAL4-associated features.
Rare ARCI genes (Causative)
Autosomal recessive
Show evidence (1 reference)
PMID:36980989 SUPPORT Human Clinical
"ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
Supports CERS3, PNPLA1, SDR9C7, and SULT2B1 as part of the established ARCI gene spectrum.
💊

Treatments

4
Topical emollients and keratolytic/supportive topical therapy
Action: supportive care MAXO:0000950
Topical treatments are first-line symptomatic management for scaling and barrier dysfunction.
Target Phenotypes: ichthyosis
Show evidence (1 reference)
PMID:38027029 SUPPORT Human Clinical
"Topical treatments are a first-choice strategy due to their ease of application and cost; however, enteral administration of retinoids offers greater efficacy, although with certain limitations."
Supports topical therapy as first-choice symptomatic treatment and retinoids as more efficacious but limited options.
Retinoid pharmacotherapy
Action: Pharmacotherapy NCIT:C15986
Agent: isotretinoin
Systemic or topical retinoid therapy is used to reduce scaling in severe inherited ichthyosis, with efficacy balanced against tolerability and safety limitations.
Target Phenotypes: ichthyosis
Show evidence (2 references)
PMID:38027029 SUPPORT Human Clinical
"Topical treatments are a first-choice strategy due to their ease of application and cost; however, enteral administration of retinoids offers greater efficacy, although with certain limitations."
Supports retinoid pharmacotherapy as a more efficacious treatment class with limitations.
clinicaltrials:NCT04154293 SUPPORT Human Clinical
"The purpose of this study is to investigate the efficacy and safety of two concentrations of topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1% isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis (CI), including..."
Supports topical isotretinoin clinical development for congenital ichthyosis including ARCI-LI.
Topical TGM1 gene therapy
Action: gene therapy MAXO:0001001
KB105 is a topical, non-integrating HSV-1 vector expressing TGM1 under clinical investigation for TGM1-deficient ARCI.
Mechanism Target:
RESTORES Cornified Envelope Cross-Linking Defect — Topical TGM1 replacement is intended to restore deficient transglutaminase 1 expression in affected skin.
Show evidence (2 references)
clinicaltrials:NCT04047732 SUPPORT Human Clinical
"This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105."
Supports clinical testing of topical KB105 for TGM1-deficient ARCI.
clinicaltrials:NCT05735158 SUPPORT Human Clinical
"KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI)."
Supports a randomized phase 2 study of KB105 in children and adults with ARCI.
IL-17A-targeting biologic therapy
Action: Pharmacotherapy NCIT:C15986
Secukinumab has been studied as mechanism-based anti-inflammatory therapy in ichthyoses, reflecting evidence of IL-17A pathway activation in ichthyosis skin rather than a proven ARCI-specific standard of care.
Target Phenotypes: ichthyosis
Show evidence (1 reference)
clinicaltrials:NCT03041038 PARTIAL Human Clinical
"The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation."
Supports inflammatory pathway targeting across ichthyoses, but this trial record is not ARCI-specific.
🔬

Clinical Trials

3
NCT04154293
Vehicle-controlled trial of topical TMB-001 isotretinoin ointment for congenital ichthyosis including ARCI-lamellar ichthyosis.
Target Phenotypes: ichthyosis
Show evidence (1 reference)
clinicaltrials:NCT04154293 SUPPORT Human Clinical
"The purpose of this study is to investigate the efficacy and safety of two concentrations of topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1% isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis (CI), including..."
Supports this trial as directly relevant to ARCI-lamellar ichthyosis.
NCT04047732
Phase I/II topical KB105 intra-patient comparison trial for TGM1-deficient ARCI.
Show evidence (1 reference)
clinicaltrials:NCT04047732 SUPPORT Human Clinical
"This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105."
Supports this trial as topical KB105 clinical testing in TGM1-deficient ARCI.
NCT05735158
Randomized placebo-controlled topical KB105 study in children and adults with ARCI.
Show evidence (1 reference)
clinicaltrials:NCT05735158 SUPPORT Human Clinical
"KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI)."
Supports this as a randomized ARCI KB105 trial record.
{ }

Source YAML

click to show
name: Autosomal Recessive Congenital Ichthyosis
creation_date: "2026-05-07T12:56:33Z"
updated_date: "2026-05-07T13:25:00Z"
category: Mendelian
description: >-
  Autosomal recessive congenital ichthyosis (ARCI) is a nonsyndromic,
  genetically heterogeneous disorder of cornification. It is defined by
  biallelic pathogenic variants in genes controlling epidermal differentiation,
  cornified-envelope cross-linking, and lipid handling, producing abnormal skin
  scaling from birth or early infancy with variable erythroderma and barrier
  compromise.
references:
- reference: DOI:10.1159/000536366
  title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: The 74-patient ARCI cohort links genotype to subtype distribution, severity, clinical signs, and ultrastructural features.
    supporting_text: >-
      The cohort included lamellar ichthyosis, congenital ichthyosiform
      erythroderma, harlequin ichthyosis, and minor ARCI subtypes with variants
      across TGM1, ALOX12B, CYP4F22, ABCA12, ALOXE3, NIPAL4, CERS3, PNPLA1,
      and SDR9C7.
- reference: DOI:10.3390/genes14030717
  title: Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis.
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: ABCA12 genotype class correlates with harlequin ichthyosis versus CIE or lamellar ichthyosis.
    supporting_text: >-
      The ABCA12 cohort supports biallelic loss-of-function variants causing
      harlequin ichthyosis and biallelic missense variants mainly causing CIE or
      lamellar ichthyosis.
- reference: DOI:10.3389/fphar.2023.1274248
  title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: ARCI treatment remains symptomatic, with topical therapy first-line and retinoids more efficacious but limited.
    supporting_text: >-
      The review describes variable desquamation with erythema, quality-of-life
      burden, first-choice topical treatments, and retinoid efficacy with
      limitations.
- reference: DOI:10.1002/mgg3.70000
  title: Genetic testing and new variants in diagnosis of congenital ichthyoses.
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: Next-generation sequencing has become a preferred diagnostic method for congenital ichthyoses.
    supporting_text: >-
      The register-based study reports genetic confirmation in 33 cases and
      states that next-generation sequencing became the genetic testing method
      of choice during the study period.
- reference: DOI:10.1007/s13555-024-01239-4
  title: Highlights of Gene and Cell Therapy for Epidermolysis Bullosa and Ichthyosis.
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: Gene and cell therapy development is underway for inherited ichthyosis and related congenital skin disorders.
    supporting_text: >-
      The review summarizes preclinical and clinical gene and cell therapy
      development for epidermolysis bullosa and ichthyosis.
- reference: DOI:10.3390/biomedicines12051112
  title: "Comprehensive Molecular Analysis of Disease-Related Genes as First-Tier Test for Early Diagnosis, Classification, and Management of Patients Affected by Nonsyndromic Ichthyosis."
  found_in:
  - Autosomal_Recessive_Congenital_Ichthyosis-deep-research-falcon.md
  findings:
  - statement: Broad molecular testing helps classify nonsyndromic ichthyosis and identifies ARCI-associated genes.
    supporting_text: >-
      The study used sequencing of more than 50 ichthyosis-related genes and
      identified ARCI associated with ALOX12B, NIPAL4, and TGM1 mutations.
synonyms:
- ARCI
- autosomal recessive inherited ichthyosis
- ichthyosis, congenital, autosomal recessive
disease_term:
  preferred_term: autosomal recessive congenital ichthyosis
  term:
    id: MONDO:0017265
    label: autosomal recessive congenital ichthyosis
parents:
- inherited ichthyosis
- disorder of cornification
has_subtypes:
- name: Lamellar Ichthyosis
  display_name: Lamellar Ichthyosis
  subtype_term:
    preferred_term: lamellar ichthyosis
    term:
      id: MONDO:0017778
      label: lamellar ichthyosis
  description: >-
    Major ARCI phenotype with generalized large scales, typically less prominent
    erythroderma, and variable ectropion or palmoplantar involvement.
  subtype_frequency: 67.5% in a 74-patient Italian ARCI cohort
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "RESULTS: Seventy-four consecutive patients (mean age 11.0 years, range 0.1-48.8) affected with lamellar ichthyosis (50/74, 67.5%), congenital ichthyosiform erythroderma (18/74, 24.3%), harlequin ichthyosis (two/74, 2.7%), and other minor ARCI subtypes (four/74, 5.4%) were enrolled."
    explanation: Supports lamellar ichthyosis as the largest major subtype in this genetically confirmed ARCI cohort.
- name: Congenital Ichthyosiform Erythroderma
  display_name: Congenital Ichthyosiform Erythroderma
  subtype_term:
    preferred_term: congenital non-bullous ichthyosiform erythroderma
    term:
      id: MONDO:0019306
      label: congenital non-bullous ichthyosiform erythroderma
  description: >-
    Major ARCI phenotype characterized by generalized scaling with more
    conspicuous erythroderma than classic lamellar ichthyosis.
  subtype_frequency: 24.3% in a 74-patient Italian ARCI cohort
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "RESULTS: Seventy-four consecutive patients (mean age 11.0 years, range 0.1-48.8) affected with lamellar ichthyosis (50/74, 67.5%), congenital ichthyosiform erythroderma (18/74, 24.3%), harlequin ichthyosis (two/74, 2.7%), and other minor ARCI subtypes (four/74, 5.4%) were enrolled."
    explanation: Supports congenital ichthyosiform erythroderma as a major ARCI subtype in a genetically confirmed cohort.
- name: Harlequin Ichthyosis
  display_name: Harlequin Ichthyosis
  subtype_term:
    preferred_term: harlequin ichthyosis
    term:
      id: MONDO:0009443
      label: autosomal recessive congenital ichthyosis 4B
  description: >-
    Severe ARCI phenotype, most often linked to ABCA12 loss-of-function, with
    profound neonatal hyperkeratosis and barrier compromise.
  subtype_frequency: 2.7% in a 74-patient Italian ARCI cohort
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The most severe form of ARCI, harlequin ichthyosis, is caused by mutations in ABCA12."
    explanation: Supports harlequin ichthyosis as the severe ABCA12-associated ARCI phenotype.
inheritance:
- name: Autosomal recessive
  inheritance_term:
    preferred_term: Autosomal recessive inheritance
    term:
      id: HP:0000007
      label: Autosomal recessive inheritance
  description: >-
    ARCI is caused by biallelic pathogenic variants in multiple causative genes.
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
    explanation: Directly supports autosomal recessive inheritance through biallelic pathogenic variants.
progression:
- phase: Congenital onset
  age_range: Birth or early neonatal period
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Autosomal recessive congenital ichthyosis (ARCI) is a non-syndromic congenital disorder of cornification characterized by abnormal scaling of the skin."
    explanation: Supports congenital onset and abnormal skin scaling as defining features.
- phase: Lifelong course
  age_range: Lifelong
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Despite the treatment alternatives, ARCI will persist throughout life, disabling people."
    explanation: Supports persistence of ARCI across the life course.
prevalence:
- population: Genetically confirmed Italian ARCI cohort
  notes: >-
    In the 74-patient Italian cohort, lamellar ichthyosis represented 67.5%,
    congenital ichthyosiform erythroderma 24.3%, harlequin ichthyosis 2.7%, and
    other minor ARCI subtypes 5.4%.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "RESULTS: Seventy-four consecutive patients (mean age 11.0 years, range 0.1-48.8) affected with lamellar ichthyosis (50/74, 67.5%), congenital ichthyosiform erythroderma (18/74, 24.3%), harlequin ichthyosis (two/74, 2.7%), and other minor ARCI subtypes (four/74, 5.4%) were enrolled."
    explanation: Provides subtype distribution in a genetically confirmed ARCI clinical cohort.
phenotypes:
- category: Dermatological
  name: Abnormal skin scaling
  frequency: Very frequent
  description: >-
    Generalized scaling is the core clinical phenotype across ARCI subtypes.
  phenotype_term:
    preferred_term: ichthyosis
    term:
      id: HP:0008064
      label: Ichthyosis
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Autosomal recessive congenital ichthyosis (ARCI) is a non-syndromic congenital disorder of cornification characterized by abnormal scaling of the skin."
    explanation: Directly supports abnormal skin scaling as a defining ARCI manifestation.
- category: Dermatological
  name: Erythroderma
  frequency: Variable
  description: >-
    Erythema accompanies scaling to a variable degree and is prominent in the
    congenital ichthyosiform erythroderma phenotype.
  phenotype_term:
    preferred_term: erythroderma
    term:
      id: HP:0001019
      label: Erythroderma
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Autosomal recessive congenital ichthyoses (ARCI) are a skin pathology due to genetic causes characterized by a variable degree of desquamation, accompanied by erythema."
    explanation: Supports erythema as a variable clinical feature accompanying desquamation in ARCI.
- category: Dermatological
  name: Hyperkeratosis
  frequency: Variable
  description: >-
    Thickened scale and generalized hyperkeratosis are most severe in harlequin
    ichthyosis and in higher-severity TGM1- or ABCA12-associated disease.
  phenotype_term:
    preferred_term: hyperkeratosis
    term:
      id: HP:0000962
      label: Hyperkeratosis
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
    explanation: Supports thick scaling, particularly in TGM1-associated ARCI.
- category: Dermatological
  name: Ectropion
  frequency: Genotype-associated
  description: >-
    Eyelid eversion is associated with more severe TGM1- and ABCA12-mutated
    ARCI.
  phenotype_term:
    preferred_term: ectropion
    term:
      id: HP:0000656
      label: Ectropion
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
    explanation: Supports ectropion as a genotype-associated clinical sign in ARCI.
- category: Dermatological
  name: Alopecia
  frequency: Genotype-associated
  description: >-
    Alopecia is associated with TGM1- and ABCA12-mutated ARCI in cohort data.
  phenotype_term:
    preferred_term: alopecia
    term:
      id: HP:0001596
      label: Alopecia
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
    explanation: Supports alopecia as a genotype-associated ARCI feature.
- category: Craniofacial
  name: Eclabium
  frequency: Genotype-associated
  description: >-
    Eversion or outward turning of the lips is associated with TGM1- and
    ABCA12-mutated ARCI in cohort data. No precise HPO term was confirmed
    locally, so this is left as preferred-term-only rather than mapped to an
    incorrect lip morphology term.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Alopecia, ectropion, and eclabium were significantly associated with TGM1 and ABCA12 mutations, and large, thick, and brownish scales with TGM1 mutations."
    explanation: Supports eclabium as a genotype-associated ARCI feature.
- category: Dermatological
  name: Pruritus and quality-of-life burden
  frequency: Variable
  description: >-
    ARCI symptoms substantially affect patient quality of life; itch is commonly
    considered in outcome measures and trials.
  phenotype_term:
    preferred_term: pruritus
    term:
      id: HP:0000989
      label: Pruritus
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: PARTIAL
    evidence_source: HUMAN_CLINICAL
    snippet: "The degree of symptoms is variable, different altered genes are involved, and the symptoms drastically affect patients' quality of life."
    explanation: Supports clinically important symptom burden but does not quantify pruritus specifically.
pathophysiology:
- name: Biallelic ARCI Gene Defects
  description: >-
    ARCI begins with biallelic pathogenic variants in a heterogeneous set of
    genes involved in epidermal cornification, lipid transport, and lipid
    metabolism.
  cell_types:
  - preferred_term: keratinocyte
    term:
      id: CL:0000312
      label: keratinocyte
  biological_processes:
  - preferred_term: keratinization
    term:
      id: GO:0031424
      label: keratinization
    modifier: ABNORMAL
  - preferred_term: lipid metabolic process
    term:
      id: GO:0006629
      label: lipid metabolic process
    modifier: ABNORMAL
  genes:
  - preferred_term: TGM1
    term:
      id: hgnc:11777
      label: TGM1
  - preferred_term: ABCA12
    term:
      id: hgnc:14637
      label: ABCA12
  - preferred_term: ALOX12B
    term:
      id: hgnc:430
      label: ALOX12B
  - preferred_term: ALOXE3
    term:
      id: hgnc:13743
      label: ALOXE3
  - preferred_term: CYP4F22
    term:
      id: hgnc:26820
      label: CYP4F22
  - preferred_term: NIPAL4
    term:
      id: hgnc:28018
      label: NIPAL4
  - preferred_term: CERS3
    term:
      id: hgnc:23752
      label: CERS3
  - preferred_term: PNPLA1
    term:
      id: hgnc:21246
      label: PNPLA1
  - preferred_term: SDR9C7
    term:
      id: hgnc:29958
      label: SDR9C7
  - preferred_term: SULT2B1
    term:
      id: hgnc:11459
      label: SULT2B1
  locations:
  - preferred_term: skin epidermis
    term:
      id: UBERON:0001003
      label: skin epidermis
  downstream:
  - target: Cornified Envelope Cross-Linking Defect
  - target: Epidermal Lipid Processing and Transport Defect
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
    explanation: Directly supports the core biallelic ARCI gene spectrum.
- name: Cornified Envelope Cross-Linking Defect
  description: >-
    TGM1-associated ARCI disrupts transglutaminase-dependent cornified-envelope
    formation in differentiating keratinocytes; this mechanism is associated
    with higher severity and thick brownish scales in cohort data.
  cell_types:
  - preferred_term: keratinocyte
    term:
      id: CL:0000312
      label: keratinocyte
  biological_processes:
  - preferred_term: epidermal cell differentiation
    term:
      id: GO:0009913
      label: epidermal cell differentiation
    modifier: ABNORMAL
  genes:
  - preferred_term: TGM1
    term:
      id: hgnc:11777
      label: TGM1
  locations:
  - preferred_term: skin epidermis
    term:
      id: UBERON:0001003
      label: skin epidermis
  downstream:
  - target: Abnormal Stratum Corneum and Barrier Phenotype
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The mean ichthyosis severity score in TGM1- and ABCA12-mutated patients was significantly higher than in all other mutated genes, while the lowest score was observed in CYP4F22-mutated patients."
    explanation: Supports TGM1 as a high-severity ARCI genotype.
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Ultrastructural data available for 56 patients showed a 100% specificity of cholesterol clefts for TGM1-mutated cases and revealed abnormal lamellar bodies in SDR9C7 and CERS3 patients."
    explanation: Supports a genotype-informative ultrastructural abnormality in TGM1-associated ARCI.
- name: Epidermal Lipid Processing and Transport Defect
  description: >-
    Multiple ARCI genes affect epidermal lipid metabolism, lipid transport, or
    acylceramide-related barrier biology. ABCA12-associated ARCI is especially
    severe when both alleles cause loss of function.
  cell_types:
  - preferred_term: keratinocyte
    term:
      id: CL:0000312
      label: keratinocyte
  biological_processes:
  - preferred_term: lipid transport
    term:
      id: GO:0006869
      label: lipid transport
    modifier: ABNORMAL
  - preferred_term: ceramide biosynthetic process
    term:
      id: GO:0046513
      label: ceramide biosynthetic process
    modifier: ABNORMAL
  - preferred_term: establishment of skin barrier
    term:
      id: GO:0061436
      label: establishment of skin barrier
    modifier: ABNORMAL
  genes:
  - preferred_term: ABCA12
    term:
      id: hgnc:14637
      label: ABCA12
  - preferred_term: ALOX12B
    term:
      id: hgnc:430
      label: ALOX12B
  - preferred_term: ALOXE3
    term:
      id: hgnc:13743
      label: ALOXE3
  - preferred_term: CYP4F22
    term:
      id: hgnc:26820
      label: CYP4F22
  - preferred_term: NIPAL4
    term:
      id: hgnc:28018
      label: NIPAL4
  - preferred_term: CERS3
    term:
      id: hgnc:23752
      label: CERS3
  - preferred_term: PNPLA1
    term:
      id: hgnc:21246
      label: PNPLA1
  - preferred_term: SDR9C7
    term:
      id: hgnc:29958
      label: SDR9C7
  - preferred_term: SULT2B1
    term:
      id: hgnc:11459
      label: SULT2B1
  locations:
  - preferred_term: skin epidermis
    term:
      id: UBERON:0001003
      label: skin epidermis
  downstream:
  - target: Abnormal Stratum Corneum and Barrier Phenotype
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Loss-of-function mutations on both alleles generally result in harlequin ichthyosis, whereas biallelic missense mutations mainly lead to CIE or LI."
    explanation: Supports ABCA12 functional severity as a determinant of the ARCI phenotype.
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Ultrastructural data available for 56 patients showed a 100% specificity of cholesterol clefts for TGM1-mutated cases and revealed abnormal lamellar bodies in SDR9C7 and CERS3 patients."
    explanation: Supports lamellar-body abnormalities in lipid-barrier ARCI genotypes.
- name: Abnormal Stratum Corneum and Barrier Phenotype
  description: >-
    Defective cornification and lipid-barrier biology converge on abnormal
    stratum corneum structure, generalized scaling, variable erythema, and
    chronic skin symptoms.
  cell_types:
  - preferred_term: keratinocyte
    term:
      id: CL:0000312
      label: keratinocyte
  biological_processes:
  - preferred_term: keratinization
    term:
      id: GO:0031424
      label: keratinization
    modifier: ABNORMAL
  - preferred_term: epidermis development
    term:
      id: GO:0008544
      label: epidermis development
    modifier: ABNORMAL
  locations:
  - preferred_term: skin epidermis
    term:
      id: UBERON:0001003
      label: skin epidermis
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Autosomal recessive congenital ichthyoses (ARCI) are a skin pathology due to genetic causes characterized by a variable degree of desquamation, accompanied by erythema."
    explanation: Supports the clinical consequence of abnormal scaling and erythema arising from genetic skin-barrier disease.
genetic:
- name: TGM1
  gene_term:
    preferred_term: TGM1
    term:
      id: hgnc:11777
      label: TGM1
  association: Causative
  inheritance:
  - name: Autosomal recessive
  notes: >-
    TGM1 was one of the two most common mutated genes in the Italian ARCI cohort
    and was associated with higher severity, alopecia, ectropion, eclabium, and
    large thick brownish scales.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
    explanation: Supports TGM1 as a common causative ARCI gene in the cohort.
- name: ALOX12B
  gene_term:
    preferred_term: ALOX12B
    term:
      id: hgnc:430
      label: ALOX12B
  association: Causative
  inheritance:
  - name: Autosomal recessive
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
    explanation: Supports ALOX12B as a common causative ARCI gene in the cohort.
- name: CYP4F22
  gene_term:
    preferred_term: CYP4F22
    term:
      id: hgnc:26820
      label: CYP4F22
  association: Causative
  inheritance:
  - name: Autosomal recessive
  notes: CYP4F22-mutated patients had the lowest mean severity score in the cohort.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The mean ichthyosis severity score in TGM1- and ABCA12-mutated patients was significantly higher than in all other mutated genes, while the lowest score was observed in CYP4F22-mutated patients."
    explanation: Supports a lower-severity CYP4F22-associated ARCI pattern in this cohort.
- name: ABCA12
  gene_term:
    preferred_term: ABCA12
    term:
      id: hgnc:14637
      label: ABCA12
  association: Causative
  inheritance:
  - name: Autosomal recessive
  variants:
  - name: ABCA12 biallelic loss-of-function variants
    description: Biallelic loss-of-function variants generally cause harlequin ichthyosis.
  - name: ABCA12 biallelic missense variants
    description: Biallelic missense variants mainly cause congenital ichthyosiform erythroderma or lamellar ichthyosis.
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The most severe form of ARCI, harlequin ichthyosis, is caused by mutations in ABCA12."
    explanation: Supports ABCA12 as the gene classically associated with harlequin ichthyosis.
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Loss-of-function mutations on both alleles generally result in harlequin ichthyosis, whereas biallelic missense mutations mainly lead to CIE or LI."
    explanation: Supports variant-class correlation for ABCA12-associated ARCI phenotypes.
- name: ALOXE3
  gene_term:
    preferred_term: ALOXE3
    term:
      id: hgnc:13743
      label: ALOXE3
  association: Causative
  inheritance:
  - name: Autosomal recessive
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Mutated genes were as follows: TGM1 in 18/74 (24.3%) patients, ALOX12B in 18/74 (24.3%), CYP4F22 in 12/74 (16.2%), ABCA12 in nine/74 (12.2%), ALOXE3 in seven/74 (9.5%), NIPAL4 in seven/74 (9.5%), and CERS3, PNPLA1, and SDR9C7 in 1 patient each (1.4%)."
    explanation: Supports ALOXE3 as a causative ARCI gene in the cohort.
- name: NIPAL4
  gene_term:
    preferred_term: NIPAL4
    term:
      id: hgnc:28018
      label: NIPAL4
  association: Causative
  inheritance:
  - name: Autosomal recessive
  notes: >-
    NIPAL4-mutated ARCI showed psoriasis-like lesions, reticulate trunk scaling,
    and striated keratoderma in the 2024 cohort.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Among specific phenotypic features, psoriasis-like lesions as well as a trunk reticulate scale pattern and striated keratoderma were present in NIPAL4-mutated patients."
    explanation: Supports distinctive NIPAL4-associated features.
- name: Rare ARCI genes
  association: Causative
  inheritance:
  - name: Autosomal recessive
  notes: >-
    CERS3, PNPLA1, SDR9C7, and SULT2B1 are established rarer ARCI genes; CERS3
    and SDR9C7 had abnormal lamellar bodies in the Italian ultrastructural
    review.
  evidence:
  - reference: PMID:36980989
    reference_title: "Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1."
    explanation: Supports CERS3, PNPLA1, SDR9C7, and SULT2B1 as part of the established ARCI gene spectrum.
diagnosis:
- name: Multigene molecular testing
  diagnosis_term:
    preferred_term: genetic testing
    term:
      id: MAXO:0000127
      label: genetic testing
  description: >-
    Diagnosis is increasingly confirmed by next-generation sequencing panels or
    broader sequencing with CNV-aware follow-up, because overlapping phenotypes
    make molecular classification important.
  results: Biallelic pathogenic variants in an ARCI gene confirm the molecular diagnosis.
  evidence:
  - reference: PMID:39189679
    reference_title: Genetic testing and new variants in diagnosis of congenital ichthyoses.
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Diagnosis of ichthyosis was confirmed with genetic testing in 33 cases, and with conventional diagnostic methods, such as clinical findings, skin biopsy and family history of ichthyoses, in 55 cases."
    explanation: Supports molecular testing as a diagnostic route for congenital ichthyoses.
  - reference: PMID:39189679
    reference_title: Genetic testing and new variants in diagnosis of congenital ichthyoses.
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "During the study period next-generation sequencing became the genetic testing method of choice providing new opportunities in diagnostics."
    explanation: Supports next-generation sequencing as the current preferred genetic testing method.
- name: Ultrastructural skin analysis
  description: >-
    Transmission electron microscopy can provide genotype-informative clues,
    including cholesterol clefts in TGM1-mutated disease and abnormal lamellar
    bodies in SDR9C7- or CERS3-associated disease.
  results: Genotype-informative ultrastructural features can support ARCI classification.
  evidence:
  - reference: PMID:38588653
    reference_title: "Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Ultrastructural data available for 56 patients showed a 100% specificity of cholesterol clefts for TGM1-mutated cases and revealed abnormal lamellar bodies in SDR9C7 and CERS3 patients."
    explanation: Supports ultrastructural skin analysis as a genotype-informative diagnostic adjunct.
treatments:
- name: Topical emollients and keratolytic/supportive topical therapy
  description: >-
    Topical treatments are first-line symptomatic management for scaling and
    barrier dysfunction.
  treatment_term:
    preferred_term: supportive care
    term:
      id: MAXO:0000950
      label: supportive care
  target_phenotypes:
  - preferred_term: ichthyosis
    term:
      id: HP:0008064
      label: Ichthyosis
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Topical treatments are a first-choice strategy due to their ease of application and cost; however, enteral administration of retinoids offers greater efficacy, although with certain limitations."
    explanation: Supports topical therapy as first-choice symptomatic treatment and retinoids as more efficacious but limited options.
- name: Retinoid pharmacotherapy
  description: >-
    Systemic or topical retinoid therapy is used to reduce scaling in severe
    inherited ichthyosis, with efficacy balanced against tolerability and safety
    limitations.
  treatment_term:
    preferred_term: Pharmacotherapy
    term:
      id: NCIT:C15986
      label: Pharmacotherapy
    therapeutic_agent:
    - preferred_term: isotretinoin
      term:
        id: CHEBI:6067
        label: isotretinoin
  target_phenotypes:
  - preferred_term: ichthyosis
    term:
      id: HP:0008064
      label: Ichthyosis
  evidence:
  - reference: PMID:38027029
    reference_title: "Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs."
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "Topical treatments are a first-choice strategy due to their ease of application and cost; however, enteral administration of retinoids offers greater efficacy, although with certain limitations."
    explanation: Supports retinoid pharmacotherapy as a more efficacious treatment class with limitations.
  - reference: clinicaltrials:NCT04154293
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The purpose of this study is to investigate the efficacy and safety of two concentrations of topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1% isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis (CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes."
    explanation: Supports topical isotretinoin clinical development for congenital ichthyosis including ARCI-LI.
- name: Topical TGM1 gene therapy
  description: >-
    KB105 is a topical, non-integrating HSV-1 vector expressing TGM1 under
    clinical investigation for TGM1-deficient ARCI.
  treatment_term:
    preferred_term: gene therapy
    term:
      id: MAXO:0001001
      label: gene therapy
  target_mechanisms:
  - target: Cornified Envelope Cross-Linking Defect
    treatment_effect: RESTORES
    description: Topical TGM1 replacement is intended to restore deficient transglutaminase 1 expression in affected skin.
  evidence:
  - reference: clinicaltrials:NCT04047732
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105."
    explanation: Supports clinical testing of topical KB105 for TGM1-deficient ARCI.
  - reference: clinicaltrials:NCT05735158
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI)."
    explanation: Supports a randomized phase 2 study of KB105 in children and adults with ARCI.
- name: IL-17A-targeting biologic therapy
  description: >-
    Secukinumab has been studied as mechanism-based anti-inflammatory therapy in
    ichthyoses, reflecting evidence of IL-17A pathway activation in ichthyosis
    skin rather than a proven ARCI-specific standard of care.
  treatment_term:
    preferred_term: Pharmacotherapy
    term:
      id: NCIT:C15986
      label: Pharmacotherapy
  target_phenotypes:
  - preferred_term: ichthyosis
    term:
      id: HP:0008064
      label: Ichthyosis
  evidence:
  - reference: clinicaltrials:NCT03041038
    supports: PARTIAL
    evidence_source: HUMAN_CLINICAL
    snippet: "The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation."
    explanation: Supports inflammatory pathway targeting across ichthyoses, but this trial record is not ARCI-specific.
clinical_trials:
- name: NCT04154293
  description: >-
    Vehicle-controlled trial of topical TMB-001 isotretinoin ointment for
    congenital ichthyosis including ARCI-lamellar ichthyosis.
  target_phenotypes:
  - preferred_term: ichthyosis
    term:
      id: HP:0008064
      label: Ichthyosis
  evidence:
  - reference: clinicaltrials:NCT04154293
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "The purpose of this study is to investigate the efficacy and safety of two concentrations of topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1% isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis (CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes."
    explanation: Supports this trial as directly relevant to ARCI-lamellar ichthyosis.
- name: NCT04047732
  description: >-
    Phase I/II topical KB105 intra-patient comparison trial for TGM1-deficient
    ARCI.
  evidence:
  - reference: clinicaltrials:NCT04047732
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "This study is an intra-patient comparison of KB105 and placebo-administered Target Areas. The primary objectives of this study are to evaluate safety and Investigator Global Assessment (IGA) scale improvement of topically administered KB105."
    explanation: Supports this trial as topical KB105 clinical testing in TGM1-deficient ARCI.
- name: NCT05735158
  description: >-
    Randomized placebo-controlled topical KB105 study in children and adults
    with ARCI.
  evidence:
  - reference: clinicaltrials:NCT05735158
    supports: SUPPORT
    evidence_source: HUMAN_CLINICAL
    snippet: "KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI)."
    explanation: Supports this as a randomized ARCI KB105 trial record.
datasets:
📚

References & Deep Research

References

6
Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses: Association of Genotype with Disease Severity, Phenotypic, and Ultrastructural Features in 74 Italian Patients.
1 finding
The 74-patient ARCI cohort links genotype to subtype distribution, severity, clinical signs, and ultrastructural features.
"The cohort included lamellar ichthyosis, congenital ichthyosiform erythroderma, harlequin ichthyosis, and minor ARCI subtypes with variants across TGM1, ALOX12B, CYP4F22, ABCA12, ALOXE3, NIPAL4, CERS3, PNPLA1, and SDR9C7."
Mutational Spectrum of the ABCA12 Gene and Genotype-Phenotype Correlation in a Cohort of 64 Patients with Autosomal Recessive Congenital Ichthyosis.
1 finding
ABCA12 genotype class correlates with harlequin ichthyosis versus CIE or lamellar ichthyosis.
"The ABCA12 cohort supports biallelic loss-of-function variants causing harlequin ichthyosis and biallelic missense variants mainly causing CIE or lamellar ichthyosis."
Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs.
1 finding
ARCI treatment remains symptomatic, with topical therapy first-line and retinoids more efficacious but limited.
"The review describes variable desquamation with erythema, quality-of-life burden, first-choice topical treatments, and retinoid efficacy with limitations."
Genetic testing and new variants in diagnosis of congenital ichthyoses.
1 finding
Next-generation sequencing has become a preferred diagnostic method for congenital ichthyoses.
"The register-based study reports genetic confirmation in 33 cases and states that next-generation sequencing became the genetic testing method of choice during the study period."
Highlights of Gene and Cell Therapy for Epidermolysis Bullosa and Ichthyosis.
1 finding
Gene and cell therapy development is underway for inherited ichthyosis and related congenital skin disorders.
"The review summarizes preclinical and clinical gene and cell therapy development for epidermolysis bullosa and ichthyosis."
Comprehensive Molecular Analysis of Disease-Related Genes as First-Tier Test for Early Diagnosis, Classification, and Management of Patients Affected by Nonsyndromic Ichthyosis.
1 finding
Broad molecular testing helps classify nonsyndromic ichthyosis and identifies ARCI-associated genes.
"The study used sequencing of more than 50 ichthyosis-related genes and identified ARCI associated with ALOX12B, NIPAL4, and TGM1 mutations."

Deep Research

1
Falcon
Key 2023–2024 highlights (executive summary)
Edison Scientific Literature 24 citations 2026-05-07T09:08:56.693208

1. Disease Information

1.1 What is the disease?

Autosomal recessive congenital ichthyosis (ARCI) is a non-syndromic, congenital disorder of cornification characterized by generalized scaling with variable erythema and barrier dysfunction, typically presenting at birth (often as a collodion baby) and persisting lifelong. (hotz2023mutationalspectrumof pages 1-2, penacorona2023advancesinthe pages 1-2)

Direct abstract quote (treatment review): “Autosomal recessive congenital ichthyoses (ARCI) are a skin pathology due to genetic causes characterized by a variable degree of desquamation, accompanied by erythema.” (Frontiers in Pharmacology; 2023-11-09) (penacorona2023advancesinthe pages 1-2)

1.2 Key identifiers

Evidence retrieved here did not include authoritative identifier pages (OMIM/Orphanet/MONDO/MeSH/ICD-10/ICD-11). Therefore, OMIM/Orphanet/MONDO/ICD/MeSH identifiers cannot be reliably asserted from this tool run.

1.3 Common synonyms / alternative names

ARCI is often used as an umbrella for major phenotypes/subtypes including: - Lamellar ichthyosis (LI) - Congenital ichthyosiform erythroderma (CIE) - Harlequin ichthyosis (HI) (most severe) - Minor/related clinical presentations: self-healing collodion baby, bathing suit ichthyosis, and related “collodion baby” neonatal presentations. (diociaiuti2024crosssectionalstudyon pages 2-3, hotz2023mutationalspectrumof pages 1-2, penacorona2023advancesinthe pages 1-2)


2. Etiology

2.1 Disease causal factors

ARCI is a Mendelian (autosomal recessive) genetic disorder caused by biallelic pathogenic variants in multiple genes involved in cornified envelope formation and epidermal lipid processing/transport, leading to skin barrier failure. (hotz2023mutationalspectrumof pages 1-2, penacorona2023advancesinthe pages 1-2)

In a 2024 Italian ARCI cohort study (n=74), the genetic distribution was: TGM1 24.3%, ALOX12B 24.3%, CYP4F22 16.2%, ABCA12 12.2%, ALOXE3 9.5%, NIPAL4 9.5%, and CERS3/PNPLA1/SDR9C7 1.4% each. (Diociaiuti et al., Dermatology; 2024-04; https://doi.org/10.1159/000536366) (diociaiuti2024crosssectionalstudyon pages 1-2)

2.2 Risk factors

  • Genetic risk: family history consistent with autosomal recessive inheritance and biallelic pathogenic variants in ARCI genes (see Section 4). (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 1-2)
  • Consanguinity can increase likelihood of autosomal recessive disease: in the 74-patient Italian series, consanguinity was 13/73 families (17.8%). (diociaiuti2024crosssectionalstudyon pages 2-3)

Evidence retrieved here did not include robust environmental, toxin, or lifestyle risk factors for ARCI as a genetic disorder.

2.3 Protective factors

No protective genetic or environmental factors were identified in the retrieved sources.

2.4 Gene–environment interactions

No explicit gene–environment interaction studies were identified in the retrieved sources.


3. Phenotypes

3.1 Core phenotype spectrum and frequencies (recent cohort data)

In a 2024 cross-sectional Italian series (74 genetically confirmed ARCI patients): - Subtype distribution: LI 67.5% (50/74); CIE 24.3% (18/74); HI 2.7% (2/74); other minor ARCI subtypes 5.4% (4/74). (diociaiuti2024crosssectionalstudyon pages 1-2) - Symptom/feature frequencies (reported across cohort): - Pruritus: 86.3% (63/73); mean itch VAS 5.7 ± 2.0 - Pain: 15.1% (11/73); pain VAS 5.2 ± 2.7 - Palmoplantar keratoderma (PPK): 97.3% (72/74) - Fissures: 28.4% (21/74) - Ectropion: 25.7% (19/74) - Eclabium: 14.9% (11/74) These data support high burden of itch and frequent keratoderma with variable ocular/perioral involvement. (diociaiuti2024crosssectionalstudyon pages 2-3)

3.2 Severity measurement in current research/practice

The Italian cohort operationalized severity using a SCORAD-based ichthyosis severity score incorporating body surface involvement, 10 clinical features, and VAS itch and pain. (diociaiuti2024crosssectionalstudyon pages 2-3)

3.3 Genotype-associated phenotypes (selected)

  • TGM1 and ABCA12 variants were associated with higher severity, and with alopecia/ectropion/eclabium. (diociaiuti2024crosssectionalstudyon pages 1-2)
  • CYP4F22 group had the lowest mean severity score in that cohort. (diociaiuti2024crosssectionalstudyon pages 1-2)
  • NIPAL4: association with psoriasis-like lesions, reticulate trunk scale, and striated keratoderma, emphasized as diagnostically relevant. (diociaiuti2024crosssectionalstudyon pages 1-2)

3.4 Quality of life impact

ARCI is described as having symptoms that “drastically affect patients’ quality of life” in a 2023 treatment review. (penacorona2023advancesinthe pages 1-2) A diagnostic-practice study also states that ichthyosis has a negative effect on QoL, citing prior literature. (salo2024genetictestingand pages 1-2)

3.5 Suggested HPO terms (examples; not exhaustive)

  • Ichthyosis/scaling: HP:0008064 (Ichthyosis), HP:0000969 (Generalized dry skin)
  • Erythroderma: HP:0001043 (Erythroderma)
  • Collodion baby: HP:0001012 (Collodion membrane)
  • Pruritus: HP:0000989 (Pruritus)
  • Palmoplantar keratoderma: HP:0000982 (Palmoplantar keratoderma)
  • Ectropion/eclabium: HP:0000656 (Ectropion), HP:0000233 (Eclabium)
  • Alopecia: HP:0001596 (Alopecia)

4. Genetic / Molecular Information

4.1 Causal genes and gene functions (current understanding)

ARCI is genetically heterogeneous; recent sources list core causal genes including ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, TGM1. (hotz2023mutationalspectrumof pages 1-2)

A large 2023 ABCA12 cohort paper states: “ARCI is caused by biallelic mutations in ABCA12, ALOX12B, ALOXE3, CERS3, CYP4F22, NIPAL4, PNPLA1, SDR9C7, SULT2B1, and TGM1.” (Genes; 2023-03; https://doi.org/10.3390/genes14030717) (hotz2023mutationalspectrumof pages 1-2)

Gene–phenotype synthesis table

Gene Protein/function (1 phrase) ARCI subtype associations Key genotype–phenotype notes/statistics Key source (include DOI and year)
TGM1 Transglutaminase-1; cornified envelope cross-linking LI, CIE, bathing suit ichthyosis; severe ARCI In the 74-patient Italian ARCI cohort, 18/74 (24.3%) had TGM1 variants; mean severity was among the highest across genes. Alopecia, ectropion, and eclabium were significantly associated with TGM1; large, thick, brownish scales were particularly linked to this genotype. On ultrastructure, cholesterol clefts were 100% specific for TGM1-mutated cases. TGM1 is also described as the most common cause of ARCI in review literature (diociaiuti2024crosssectionalstudyon pages 1-2, penacorona2023advancesinthe pages 1-2). Diociaiuti 2024, DOI: 10.1159/000536366; Peña-Corona 2023, DOI: 10.3389/fphar.2023.1274248 (diociaiuti2024crosssectionalstudyon pages 1-2, penacorona2023advancesinthe pages 1-2)
ALOX12B 12R-lipoxygenase; epidermal lipid processing LI, CIE, collodion baby/self-improving phenotypes In the Italian cohort, 18/74 (24.3%) had ALOX12B variants, tying TGM1 as the most frequent gene. Severity was lower than TGM1/ABCA12 overall. Reviews identify ALOX12B as a major ARCI gene involved in barrier lipid metabolism; phenotypes can range from collodion baby to later generalized ichthyosis (diociaiuti2024crosssectionalstudyon pages 1-2, penacorona2023advancesinthe pages 1-2). Diociaiuti 2024, DOI: 10.1159/000536366; Peña-Corona 2023, DOI: 10.3389/fphar.2023.1274248 (diociaiuti2024crosssectionalstudyon pages 1-2, penacorona2023advancesinthe pages 1-2)
CYP4F22 Cytochrome P450 ω-hydroxylase; acylceramide synthesis LI/CIE spectrum, often milder ARCI In the Italian cohort, 12/74 (16.2%) had CYP4F22 variants. This group had the lowest mean ichthyosis severity score among the common ARCI genes in that study. Founder effects are reported for some variants in prior population studies, supporting population-specific enrichment (diociaiuti2024crosssectionalstudyon pages 1-2). Diociaiuti 2024, DOI: 10.1159/000536366 (diociaiuti2024crosssectionalstudyon pages 1-2)
ABCA12 Lipid transporter for lamellar granule cargo/glucosylceramides HI, also LI and CIE In the Italian cohort, 9/74 (12.2%) had ABCA12 variants; severity was among the highest and alopecia, ectropion, eclabium were significantly associated. In the dedicated 64-patient ABCA12 cohort, 34 novel variants expanded the known spectrum to 217 mutations; putative hotspots included c.4541G>A p.(Arg1514His) and c.4139A>G p.(Asn1380Ser). Strong correlation: biallelic loss-of-function usually causes HI, whereas biallelic missense variants mainly cause CIE or LI (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 1-2). Hotz 2023, DOI: 10.3390/genes14030717; Diociaiuti 2024, DOI: 10.1159/000536366 (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 1-2)
ALOXE3 Epidermal lipoxygenase eLOX3; lipid barrier metabolism LI/CIE spectrum In the Italian cohort, 7/74 (9.5%) had ALOXE3 variants. Included among core ARCI genes in multiple recent reviews and diagnostic papers; phenotype overlaps with other lipid-metabolism ARCI genes, supporting need for molecular confirmation (diociaiuti2024crosssectionalstudyon pages 1-2, fioretti2024comprehensivemolecularanalysis pages 16-17). Diociaiuti 2024, DOI: 10.1159/000536366; Fioretti 2024, DOI: 10.3390/biomedicines12051112 (diociaiuti2024crosssectionalstudyon pages 1-2, fioretti2024comprehensivemolecularanalysis pages 16-17)
NIPAL4 Ichthyin; epidermal lipid homeostasis/acylceramide pathway LI/CIE spectrum, distinctive patterned/psoriasiform ARCI In the Italian cohort, 7/74 (9.5%) had NIPAL4 variants. Distinctive associations included psoriasis-like lesions, reticulate trunk scale pattern, and striated keratoderma; these were highlighted as a novel phenotypic feature with possible diagnostic/therapeutic implications. Prior referenced literature also links NIPAL4 to reduced stratum corneum acylceramides (diociaiuti2024crosssectionalstudyon pages 1-2, diociaiuti2024crosssectionalstudyon pages 17-17). Diociaiuti 2024, DOI: 10.1159/000536366 (diociaiuti2024crosssectionalstudyon pages 1-2, diociaiuti2024crosssectionalstudyon pages 17-17)
CERS3 Ceramide synthase 3; very-long-chain ceramide synthesis Rare ARCI, LI/CIE-like phenotypes Rare in the Italian cohort (1/74; 1.4%). Ultrastructural review showed abnormal lamellar bodies in the CERS3 case, consistent with a barrier-lipid trafficking/synthesis defect (diociaiuti2024crosssectionalstudyon pages 1-2). Diociaiuti 2024, DOI: 10.1159/000536366 (diociaiuti2024crosssectionalstudyon pages 1-2)
PNPLA1 Patatin-like phospholipase; acylceramide biosynthesis Rare ARCI, typically LI/CIE-like Rare in the Italian cohort (1/74; 1.4%). Included among established ARCI genes in recent reviews and sequencing studies; contributes to defective epidermal lipid barrier formation (diociaiuti2024crosssectionalstudyon pages 1-2, hotz2023mutationalspectrumof pages 1-2). Diociaiuti 2024, DOI: 10.1159/000536366; Hotz 2023, DOI: 10.3390/genes14030717 (diociaiuti2024crosssectionalstudyon pages 1-2, hotz2023mutationalspectrumof pages 1-2)
SDR9C7 Short-chain dehydrogenase/reductase; epidermal retinoid/vitamin A-related metabolism Rare ARCI, LI/CIE-like Rare in the Italian cohort (1/74; 1.4%). Ultrastructural analysis showed abnormal lamellar bodies in the SDR9C7 patient; referenced literature links SDR9C7 to impaired epidermal barrier function and vitamin A metabolism (diociaiuti2024crosssectionalstudyon pages 1-2, diociaiuti2024crosssectionalstudyon pages 17-17). Diociaiuti 2024, DOI: 10.1159/000536366 (diociaiuti2024crosssectionalstudyon pages 1-2, diociaiuti2024crosssectionalstudyon pages 17-17)
SULT2B1 Cholesterol sulfotransferase; epidermal sterol metabolism Rare ARCI / nonsyndromic ichthyosis Not represented among the 74 Italian patients, but listed as an established ARCI gene in recent ABCA12-focused and multi-gene diagnostic papers. Multi-gene NGS studies support inclusion of SULT2B1 on ichthyosis panels because phenotype overlaps with other ARCI forms (hotz2023mutationalspectrumof pages 1-2, fioretti2024comprehensivemolecularanalysis pages 16-17). Hotz 2023, DOI: 10.3390/genes14030717; Fioretti 2024, DOI: 10.3390/biomedicines12051112 (hotz2023mutationalspectrumof pages 1-2, fioretti2024comprehensivemolecularanalysis pages 16-17)

Table: This table summarizes major ARCI genes, their biological roles, subtype associations, and the most informative genotype–phenotype findings from the provided evidence. It emphasizes cohort-based frequencies from Diociaiuti 2024 and the ABCA12-specific correlations from Hotz 2023 for diagnostic and knowledge-base use.

4.2 Pathogenic variants and variant classes

  • ABCA12 (2023 cohort, n=64): identified 34 novel ABCA12 mutations, expanding the reported spectrum to 217 mutations and noting possible hotspots c.4541G>A p.(Arg1514His) and c.4139A>G p.(Asn1380Ser). (hotz2023mutationalspectrumof pages 1-2)
  • Genotype–phenotype rule (ABCA12): “Loss-of-function mutations on both alleles generally result in harlequin ichthyosis, whereas biallelic missense mutations mainly lead to CIE or LI.” (hotz2023mutationalspectrumof pages 1-2)
  • ARCI cohort (Italy, 2024): identified 25 previously undescribed mutations, plus structural events (microduplications in TGM1, microdeletions in CYP4F22 and NIPAL4), illustrating that CNVs are relevant in ARCI diagnostics. (diociaiuti2024crosssectionalstudyon pages 1-2)

4.3 Modifier genes

No validated modifier genes were identified in the retrieved sources.

4.4 Epigenetic information

No ARCI-specific epigenetic mechanisms were identified in the retrieved sources.

4.5 Chromosomal abnormalities

Structural variants (CNVs) were reported in ARCI genes in the 2024 Italian cohort (microduplications/microdeletions), supporting CNV-aware diagnostic pipelines. (diociaiuti2024crosssectionalstudyon pages 1-2)


5. Environmental Information

No consistent non-genetic environmental causes were identified in the retrieved sources, consistent with ARCI being primarily monogenic. Supportive care often includes environmental management (e.g., avoiding overheating due to hypohidrosis/heat intolerance), but specific external causal exposures were not established in these sources. (diociaiuti2024crosssectionalstudyon pages 2-3)


6. Mechanism / Pathophysiology

6.1 Current mechanistic model (upstream→downstream causal chain)

Upstream trigger: biallelic pathogenic variants in genes mediating cornified envelope formation (e.g., TGM1) and/or epidermal lipid transport/metabolism (e.g., ABCA12, lipoxygenases, acylceramide pathway genes). (hotz2023mutationalspectrumof pages 1-2, penacorona2023advancesinthe pages 1-2)

Intermediate biological effects: defective cornification and impaired lipid processing/transport produce an abnormal stratum corneum architecture and permeability barrier; ultrastructural signatures can be gene-informative (e.g., “cholesterol clefts” in TGM1). (diociaiuti2024crosssectionalstudyon pages 1-2)

Clinical manifestations: generalized hyperkeratosis/scaling with variable erythema, fissuring, ectropion/eclabium, pruritus and pain; severe ABCA12 loss-of-function produces harlequin ichthyosis with life-threatening neonatal complications. (diociaiuti2024crosssectionalstudyon pages 2-3, hotz2023mutationalspectrumof pages 1-2)

6.2 Inflammatory/immune involvement (emerging theme)

A 2023 treatment review frames ARCI as having an “inflammatory process” and motivates repurposing biologics based on overlapping immune signatures with psoriasis/atopic dermatitis. (penacorona2023advancesinthe pages 1-2) Clinical trial development targeting IL-17 (secukinumab) and IL-12/23 (ustekinumab) further reflects this mechanistic direction. (NCT03041038 chunk 1, penacorona2023advancesinthe pages 6-7)

6.3 Suggested ontology mappings

  • GO Biological Process (examples): keratinization; epidermis development; lipid metabolic process; establishment of skin barrier.
  • Cell types (CL): CL:0000312 keratinocyte; (optionally) differentiated keratinocytes/corneocytes.
  • Anatomy (UBERON): UBERON:0002097 skin of body; UBERON:0001003 epidermis; stratum corneum.

7. Anatomical Structures Affected

7.1 Organ/system level

Primary organ: skin (epidermis/stratum corneum). (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 1-2) Secondary/complication-relevant systems include eyes (ectropion), mouth/lips (eclabium), thermoregulation (hypohidrosis/heat intolerance), and infection susceptibility due to barrier compromise. (diociaiuti2024crosssectionalstudyon pages 2-3)

7.2 Tissue/cell level

Key affected tissue: keratinizing stratified squamous epithelium of the epidermis; key cell type: keratinocytes undergoing abnormal terminal differentiation/cornification. (penacorona2023advancesinthe pages 1-2)

7.3 Subcellular/cellular components (suggested)

Cornified envelope structures and lipid-processing/transport organelles (e.g., lamellar body biology) are implicated; ultrastructural abnormalities were used diagnostically (including abnormal lamellar bodies in CERS3/SDR9C7 cases). (diociaiuti2024crosssectionalstudyon pages 1-2)


8. Temporal Development

8.1 Onset

ARCI is typically congenital/early-onset; the “collodion baby” presentation is frequently described across ARCI. (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 2-3)

8.2 Progression

The 2024 cohort includes ages from infancy to adulthood (0.1–48.8 years), supporting the view that ARCI is generally chronic and lifelong, with variable severity across genotypes. (diociaiuti2024crosssectionalstudyon pages 1-2)


9. Inheritance and Population

9.1 Inheritance

Autosomal recessive inheritance is explicit in the disease definition. (hotz2023mutationalspectrumof pages 1-2)

9.2 Epidemiology (available estimates in retrieved sources)

A 2023 ARCI treatment review cites: - TGM1-related prevalence “at 1:100,000 population” (citing Vahlquist et al., 2008), and - a French epidemiologic study reporting ARCI prevalence 7:1,000,000 (citing Dreyfus et al., 2014). (penacorona2023advancesinthe pages 1-2)

Because these are secondary citations within a review, they should be treated as contextual estimates rather than definitive contemporary global prevalence.

9.3 Population structure: consanguinity

The 2024 Italian cohort reported 17.8% consanguinity (13/73 families). (diociaiuti2024crosssectionalstudyon pages 2-3)


10. Diagnostics

10.1 Clinical diagnosis and differential diagnosis

Diagnosis generally starts from clinical phenotype (LI/CIE/HI spectrum, collodion baby) and is increasingly confirmed by genetic testing. (diociaiuti2024crosssectionalstudyon pages 1-2, salo2024genetictestingand pages 1-2)

10.2 Histopathology/ultrastructure as diagnostic support

The 2024 Italian ARCI study incorporated transmission electron microscopy and reported gene-informative ultrastructural patterns (e.g., “cholesterol clefts” specific for TGM1). (diociaiuti2024crosssectionalstudyon pages 1-2)

10.3 Genetic testing: current real-world approach

A 2024 register-based Finnish study (2000–2020; n=88) describes how diagnostic practice evolved: - “Diagnosis of ichthyosis was confirmed with genetic testing in 33 cases … and with conventional diagnostic methods … in 55 cases.” (Accepted 2024-08-06; https://doi.org/10.1002/mgg3.70000) (salo2024genetictestingand pages 1-2) - “When genetic testing became available, it was offered primarily to patients with severe forms of ichthyosis. During the study period next-generation sequencing became the genetic testing method of choice…” (salo2024genetictestingand pages 1-2)

The 2024 Italian cohort used targeted NGS panels and escalation to clinical exome/other methods, plus qPCR/array CGH for CNV detection and Sanger validation. (diociaiuti2024crosssectionalstudyon pages 2-3)

10.4 Suggested testing algorithm (evidence-aligned)

1) Phenotype-driven evaluation (LI/CIE/HI; collodion baby) with assessment of extracutaneous features to exclude syndromic ichthyoses. (salo2024genetictestingand pages 1-2) 2) NGS multigene panel covering core ARCI genes; consider CNV-aware methods (microarray/MLPA/NGS CNV calling) given reported microdeletions/duplications. (diociaiuti2024crosssectionalstudyon pages 1-2, salo2024genetictestingand pages 1-2) 3) If negative/uncertain: clinical exome or genome sequencing; segregation analysis where needed. (diociaiuti2024crosssectionalstudyon pages 2-3, salo2024genetictestingand pages 1-2)


11. Outcome / Prognosis

The retrieved sources emphasize clinical heterogeneity and mention improved outcomes for severe forms with intensive neonatal care, but they do not provide cohort-level survival curves for ARCI/HI within 2023–2024 primary literature in this run. The Italian cohort supports long-term survivorship into adulthood across subtypes, while HI is highlighted as the most severe and high-burden neonatal condition. (hotz2023mutationalspectrumof pages 1-2, diociaiuti2024crosssectionalstudyon pages 1-2)


12. Treatment

12.1 Current standard management (symptom-directed)

A 2023 review states: “Topical treatments are a first-choice strategy due to their ease of application and cost; however, enteral administration of retinoids offers greater efficacy, although with certain limitations.” (Published 2023-11-09; https://doi.org/10.3389/fphar.2023.1274248) (penacorona2023advancesinthe pages 1-2)

12.2 Systemic retinoids and alternatives

The retrieved evidence establishes systemic retinoids as commonly used in severe inherited ichthyosis management (review-level statement), but does not provide ARCI-specific response rates in 2023–2024 primary trials in this run. (penacorona2023advancesinthe pages 1-2)

12.3 Recent developments and real-world implementations (prioritizing 2023–2024)

(A) Topical isotretinoin (TMB-001) — late-phase repurposing in congenital ichthyosis

Trial: NCT04154293 (Timber Pharmaceuticals; Phase 2; completed). (NCT04154293 chunk 1) - Population: age ≥9 years, genetically confirmed congenital ichthyosis including ARCI-LI and RXLI; 10–90% BSA involvement. (NCT04154293 chunk 1) - Design: randomized, double-blind, vehicle-controlled; 34 participants; 1:1:1 to 0.05% BID, 0.1% BID, or vehicle for 12 weeks. (Study start 2019-12-03; completion 2021-08-30) (NCT04154293 chunk 1) - Primary endpoint: VIIS-50 responder at Week 12 (≥50% reduction in VIIS scaling). (NCT04154293 chunk 1) - Patient-centered secondary endpoints included itch scale change and DLQI. (NCT04154293 chunk 1) URL: https://clinicaltrials.gov/study/NCT04154293 (registry-derived). (NCT04154293 chunk 1)

(B) Topical gene replacement for TGM1-deficient ARCI — KB105 (HSV-1 vector)

Gene/cell therapy review (2024) states: “Gene therapy for the most common type of ichthyosis, lamellar ichthyosis caused by biallelic pathogenic variants in TGM1, is currently being developed using an engineered herpes simplex virus type 1 vector.” (Published online 2024-08-07; https://doi.org/10.1007/s13555-024-01239-4) (koutsoukos2024highlightsofgene pages 1-3)

ClinicalTrials.gov trials: - NCT04047732 (KB105; Phase 1/2; single-group, intra-patient comparison; up to 6 adults; started 2019-08-27; primary completion estimated Oct 2022; completion estimated Mar 2025). Endpoints include safety (TEAEs) and improvement by Investigator’s Global Assessment (IGA), VIIS-L changes, and immunofluorescence measurement of TGM1 in treated skin. (NCT04047732 chunk 1) - NCT05735158 (KB105-02; Phase 2; randomized, placebo-controlled, double-blind intra-subject design; estimated 15; weekly dosing; primary endpoint Composite IGA responder at Week 9; includes systemic retinoid stability/washout rules). (Posted as 2023 trial record; sponsor Krystal Biotech) (NCT05735158 chunk 1) URLs: https://clinicaltrials.gov/study/NCT04047732 and https://clinicaltrials.gov/study/NCT05735158 (registry-derived). (NCT04047732 chunk 1, NCT05735158 chunk 1)

(C) Anti–IL-17A biologic therapy (secukinumab) — mechanism-based repositioning

Trial: NCT03041038 (Northwestern University; Phase 2; completed; results posted 2021). (NCT03041038 chunk 1) - Enrollment: 20 adults. - Dosing: secukinumab 300 mg SC weekly ×5 then monthly vs placebo with crossover/open-label phases. (NCT03041038 chunk 1) - Primary efficacy endpoint: Week 16 reduction in Ichthyosis Area Severity Index (IASI). - Primary safety endpoint: bacterial/fungal mucocutaneous infections through Week 16. (NCT03041038 chunk 1) URL: https://clinicaltrials.gov/study/NCT03041038 (registry-derived). (NCT03041038 chunk 1)

(D) Anti–IL-12/23 (ustekinumab) — trial-scale testing in ichthyoses

A 2023 ARCI repositioning review notes a trial “with 13 participants receiving injections every 8 weeks for one year” aiming to reduce severity and assess infection safety endpoints (review-level summary). (penacorona2023advancesinthe pages 6-7)

12.4 MAXO (Medical Action Ontology) suggestions (examples)

  • Topical emollient therapy; keratolytic therapy; systemic retinoid therapy; topical retinoid therapy; biologic anti–IL-17 therapy; biologic anti–IL-12/23 therapy; gene replacement therapy (topical viral vector).

13. Prevention

Primary prevention is genetic (not environmental): carrier testing, prenatal diagnosis, and reproductive counseling are standard concepts for autosomal recessive disorders, but explicit ARCI-specific prevention guideline statements were not retrieved in this run. Genetic counseling is emphasized as enabled by molecular diagnosis in diagnostic-practice literature. (salo2024genetictestingand pages 1-2)


14. Other Species / Natural Disease

The retrieved sources in this run do not provide primary evidence for naturally occurring ARCI-equivalent disease across species. (No species-specific evidence retrieved.)


15. Model Organisms

The retrieved sources in this run mention that gene and cell therapy development for ichthyosis is supported by preclinical work (review-level), but do not provide specific animal model identifiers or detailed phenotype recapitulation for ARCI subtypes in the captured excerpts. (koutsoukos2024highlightsofgene pages 1-3)


Key 2023–2024 highlights (executive summary)

1) Genotype–phenotype resolution is improving with large cohorts: a 2024 single-center ARCI cohort (n=74) provides gene frequencies and statistically associated clinical features and ultrastructural signatures (including itch burden and high prevalence of PPK). (diociaiuti2024crosssectionalstudyon pages 2-3, diociaiuti2024crosssectionalstudyon pages 1-2) 2) ABCA12 genotype–phenotype correlation is reinforced: biallelic loss-of-function → HI; biallelic missense → LI/CIE; 34 novel variants in a 64-patient cohort (2023). (hotz2023mutationalspectrumof pages 1-2) 3) Diagnostics are shifting to NGS as first-tier with increasing use over time and improved classification/prognosis and counseling; conventional methods remain common where testing is unavailable (2024 register study). (salo2024genetictestingand pages 1-2) 4) Therapeutic innovation is moving toward targeted biologics and gene therapy: topical HSV-1–vector TGM1 gene therapy trials are ongoing/expanding; topical isotretinoin and IL-17 blockade have been tested in controlled trial frameworks. (koutsoukos2024highlightsofgene pages 1-3, NCT04047732 chunk 1, NCT05735158 chunk 1, NCT04154293 chunk 1, NCT03041038 chunk 1)


URLs and publication dates for key cited sources

  • Diociaiuti et al. “Cross-Sectional Study on Autosomal Recessive Congenital Ichthyoses…” Apr 2024. DOI/URL: https://doi.org/10.1159/000536366 (diociaiuti2024crosssectionalstudyon pages 1-2)
  • Hotz et al. “Mutational Spectrum of the ABCA12 Gene…” Mar 2023. DOI/URL: https://doi.org/10.3390/genes14030717 (hotz2023mutationalspectrumof pages 1-2)
  • Peña‑Corona et al. “Advances in the treatment of autosomal recessive congenital ichthyosis…” Published 2023-11-09. DOI/URL: https://doi.org/10.3389/fphar.2023.1274248 (penacorona2023advancesinthe pages 1-2)
  • Salo et al. “Genetic testing and new variants in diagnosis of congenital ichthyoses” Accepted 2024-08-06. DOI/URL: https://doi.org/10.1002/mgg3.70000 (salo2024genetictestingand pages 1-2)
  • Koutsoukos & Bilousova “Highlights of Gene and Cell Therapy…” Published online 2024-08-07. DOI/URL: https://doi.org/10.1007/s13555-024-01239-4 (koutsoukos2024highlightsofgene pages 1-3)
  • ClinicalTrials.gov: NCT04154293 https://clinicaltrials.gov/study/NCT04154293 (NCT04154293 chunk 1)
  • ClinicalTrials.gov: NCT04047732 https://clinicaltrials.gov/study/NCT04047732 (NCT04047732 chunk 1)
  • ClinicalTrials.gov: NCT05735158 https://clinicaltrials.gov/study/NCT05735158 (NCT05735158 chunk 1)
  • ClinicalTrials.gov: NCT03041038 https://clinicaltrials.gov/study/NCT03041038 (NCT03041038 chunk 1)

References

  1. (diociaiuti2024crosssectionalstudyon pages 2-3): Andrea Diociaiuti, Marialuisa Corbeddu, Sabrina Rossi, Elisa Pisaneschi, Claudia Cesario, Angelo Giuseppe Condorelli, Tonia Samela, Simona Giancristoforo, Adriano Angioni, Giovanna Zambruno, Antonio Novelli, Rita Alaggio, Damiano Abeni, and May El Hachem. Cross-sectional study on autosomal recessive congenital ichthyoses: association of genotype with disease severity, phenotypic, and ultrastructural features in 74 italian patients. Dermatology (Basel, Switzerland), 240:397-413, Apr 2024. URL: https://doi.org/10.1159/000536366, doi:10.1159/000536366. This article has 10 citations.

  2. (hotz2023mutationalspectrumof pages 1-2): Alrun Hotz, Julia Kopp, Emmanuelle Bourrat, Vinzenz Oji, Kira Süßmuth, Katalin Komlosi, Bakar Bouadjar, Iliana Tantcheva-Poór, Maritta Hellström Pigg, Regina Betz, Kathrin Giehl, Fiona Schedel, Lisa Weibel, Solveig Schulz, Dora Stölzl, Gianluca Tadini, Emine Demiral, Karin Berggard, Andreas Zimmer, Svenja Alter, and Judith Fischer. Mutational spectrum of the abca12 gene and genotype–phenotype correlation in a cohort of 64 patients with autosomal recessive congenital ichthyosis. Genes, 14:717, Mar 2023. URL: https://doi.org/10.3390/genes14030717, doi:10.3390/genes14030717. This article has 27 citations.

  3. (penacorona2023advancesinthe pages 1-2): Sheila I. Peña-Corona, Stephany Celeste Gutiérrez-Ruiz, Ma de los Dolores Campos Echeverria, Hernán Cortés, Manuel González-Del Carmen, and Gerardo Leyva-Gómez. Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs. Frontiers in Pharmacology, Nov 2023. URL: https://doi.org/10.3389/fphar.2023.1274248, doi:10.3389/fphar.2023.1274248. This article has 9 citations.

  4. (salo2024genetictestingand pages 1-2): Milja Salo, Teija Kimpimäki, Heini Huhtala, and Tanja Saarela. Genetic testing and new variants in diagnosis of congenital ichthyoses. Molecular Genetics & Genomic Medicine, Aug 2024. URL: https://doi.org/10.1002/mgg3.70000, doi:10.1002/mgg3.70000. This article has 1 citations and is from a peer-reviewed journal.

  5. (NCT04047732 chunk 1): Topical KB105 Gene Therapy for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI). Krystal Biotech, Inc.. 2019. ClinicalTrials.gov Identifier: NCT04047732

  6. (diociaiuti2024crosssectionalstudyon pages 1-2): Andrea Diociaiuti, Marialuisa Corbeddu, Sabrina Rossi, Elisa Pisaneschi, Claudia Cesario, Angelo Giuseppe Condorelli, Tonia Samela, Simona Giancristoforo, Adriano Angioni, Giovanna Zambruno, Antonio Novelli, Rita Alaggio, Damiano Abeni, and May El Hachem. Cross-sectional study on autosomal recessive congenital ichthyoses: association of genotype with disease severity, phenotypic, and ultrastructural features in 74 italian patients. Dermatology (Basel, Switzerland), 240:397-413, Apr 2024. URL: https://doi.org/10.1159/000536366, doi:10.1159/000536366. This article has 10 citations.

  7. (fioretti2024comprehensivemolecularanalysis pages 16-17): Tiziana Fioretti, Fabrizio Martora, Ilaria De Maggio, Adelaide Ambrosio, Carmelo Piscopo, Sabrina Vallone, Felice Amato, Diego Passaro, Fabio Acquaviva, Francesca Gaudiello, Daniela Di Girolamo, Valeria Maiolo, Federica Zarrilli, Speranza Esposito, Giuseppina Vitiello, Luigi Auricchio, Elena Sammarco, Daniele De Brasi, Roberta Petillo, Antonella Gambale, Fabio Cattaneo, Rosario Ammendola, Paola Nappa, and Gabriella Esposito. Comprehensive molecular analysis of disease-related genes as first-tier test for early diagnosis, classification, and management of patients affected by nonsyndromic ichthyosis. Biomedicines, 12:1112, May 2024. URL: https://doi.org/10.3390/biomedicines12051112, doi:10.3390/biomedicines12051112. This article has 2 citations.

  8. (diociaiuti2024crosssectionalstudyon pages 17-17): Andrea Diociaiuti, Marialuisa Corbeddu, Sabrina Rossi, Elisa Pisaneschi, Claudia Cesario, Angelo Giuseppe Condorelli, Tonia Samela, Simona Giancristoforo, Adriano Angioni, Giovanna Zambruno, Antonio Novelli, Rita Alaggio, Damiano Abeni, and May El Hachem. Cross-sectional study on autosomal recessive congenital ichthyoses: association of genotype with disease severity, phenotypic, and ultrastructural features in 74 italian patients. Dermatology (Basel, Switzerland), 240:397-413, Apr 2024. URL: https://doi.org/10.1159/000536366, doi:10.1159/000536366. This article has 10 citations.

  9. (NCT03041038 chunk 1): Amy Paller. The Efficacy and Safety of Secukinumab in Patients With Ichthyoses. Northwestern University. 2016. ClinicalTrials.gov Identifier: NCT03041038

  10. (penacorona2023advancesinthe pages 6-7): Sheila I. Peña-Corona, Stephany Celeste Gutiérrez-Ruiz, Ma de los Dolores Campos Echeverria, Hernán Cortés, Manuel González-Del Carmen, and Gerardo Leyva-Gómez. Advances in the treatment of autosomal recessive congenital ichthyosis, a look towards the repositioning of drugs. Frontiers in Pharmacology, Nov 2023. URL: https://doi.org/10.3389/fphar.2023.1274248, doi:10.3389/fphar.2023.1274248. This article has 9 citations.

  11. (NCT04154293 chunk 1): A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis. Timber Pharmaceuticals Inc.. 2019. ClinicalTrials.gov Identifier: NCT04154293

  12. (koutsoukos2024highlightsofgene pages 1-3): Stefanos A. Koutsoukos and Ganna Bilousova. Highlights of gene and cell therapy for epidermolysis bullosa and ichthyosis. Dermatology and Therapy, 14:2379-2392, Aug 2024. URL: https://doi.org/10.1007/s13555-024-01239-4, doi:10.1007/s13555-024-01239-4. This article has 5 citations.

  13. (NCT05735158 chunk 1): Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI). Krystal Biotech, Inc.. 2023. ClinicalTrials.gov Identifier: NCT05735158