Health Condition 1: Q80- Congenital ichthyosis
Conditions
Interventions
Intervention1: Vitamin D: Vitamin D (tablet) given at a dose of 2000 IU once/day for 24 weeks
Control Intervention1: Acitretin: Acitretin (capsule) at a dose of 0.5 mg/kg once/day given orally for 24
Sponsors
Department of Dermatology Venereology and Leprology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Non syndromic congenital ichthyosis patients regardless of age and sex. 2.Women of child bearing potential if using adequate contraception. 3.Patients with either normal vitamin D levels or low vitamin D levels not having any clinical or radiological manifestations of rickets. 4.Patients who can give valid consent. 5.Willing for monthly follow-up visits for at least 6 months.
Exclusion criteria
Exclusion criteria: 1.Ichthyosis vulgaris 2.XLRI involving less than 10% body surface area. 3.Pregnant and lactating mothers. 4.Systemic treatment within 4 weeks prior to the start of treatment phase. 5.Patients with hypercalcemia or high vitamin D, and significant renal or hepatic disease. 6.Patients with severe hypovitaminosis D affecting bone health as assessed clinically and radiologically. 7.Inability to come for monthly follow up visits for 6 months 8.Those who cannot provide consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in Visual Index for Ichthyosis Severity for scale and erythema at weeks 0 and 24 between Vitamin D and acitretin armTimepoint: Week 0 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events for patients with each treatmentTimepoint: Week 0 to 24;Mean difference in pre and post treatment mRNA levels of RORγt and IL 17 in PBMCTimepoint: Week 0 and 24;Mean difference in quality of life as measured by IQoL-32 at weeks 0 and 24 between Vitamin D and acitretin armTimepoint: Week 0 and 24 | — |
Countries
India
Contacts
Public ContactDr Rahul Mahajan
PGIMER
Outcome results
None listed