A comparative trial studying the molecular action of vitamin D and retinoids (acitretin) in children with autosomal recessive congenital ichthyosis

A Phase II randomized controlled trial elucidating the gene expression profile using transcriptomic analysis in children with autosomal recessive congenital ichthyosis treated with vitamin D and acitretin.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009565

Enrollment

Registered

2017-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- autosomal recessive congenital ichthyosis with vitamin D Deficiency

Interventions

Intervention1: Vitamin D: Oral cholecalciferol 60,000 IU daily for 7 days under supervision followed by 1000 IU daily for 25 days so as to complete 1 month of treatment. Elemental calcium at a dose

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients of autosomal recessive congenital ichthyosis belonging to either lamellar or congenital ichthyosiform erythroderma phenotypes. Lamellar Ichthyosis: a. Children with large parchment like scales all over the body b. Scales are larger, severely thicker and brownish that might fracture resulting in tessellated or tile like pattern. c. Hyperkeratotic and more verrucous scaling around the joints d. Erythroderma e. Severe ectropion Congenital Ichthyosiform erythroderma f. Prominent erythroderma g. Scaling is present all over the body, less severe than seen in lamellar phenotype. h. Scales are lighter and thinner 2. Serum 25 (OH) D levels 3. Age > 6 months

Exclusion criteria

Exclusion criteria: 1. Other variants of congenital Ichthyosis (Ichthyosis vulgaris, X linked recessive ichthyosis, epidermolytic ichthyosis) 2. Children with liver and kidney impairment or any other systemic illness.

Design outcomes

Primary

Measure	Time frame
1. Gene expression profile before and after 1 month of intervention 2. Clinical photographic evaluation scores before and after intervention 3. Biochemical evaluation before and after intervention. 4. TEWL and corneal hydration before and after intervention (if possible) Timepoint: At base line and 1 month after intervention	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactTanvi Dev

Department of Dermatology All India Institute of Medical Sciences New Delhi

aiimsgsr@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026