Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Oral Acitretin + Ustekinumab Injection: Oral acitretin (0.5 mg/kg/day) for 24 weeks plus ustekinumab administered subcutaneously at 0.75 mg/kg (less than 60 kg), 45 mg (60 100 kg) or 90
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged more than 6 years with genetically or clinically confirmed non syndromic congenital ichthyosis or netherton syndrome will be included
Exclusion criteria
Exclusion criteria: Exclusion criteria will include syndromic ichthyosis, common ichthyosis (XLRI/ichthyosis vulgaris), recent use of systemic retinoids (within 8 weeks) or biologics (within 12 weeks), active infection, significant hepatic/renal dysfunction, uncontrolled hyperlipidemia, pregnancy/lactation, or contraindications to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute change in ichthyosis area severity index (IASI)Timepoint: Baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Index for Ichthyosis SeverityTimepoint: Weeks 0, 4, 8, 12, 20, and 24;Proportion achieving more than or equal to 50% reduction in IASITimepoint: Week 24;Incidence of adverse eventsTimepoint: Weeks 4, 8, 12, 20, and 24;Mean change in serum IL-23 and other IL-23/Th17 related cytokinesTimepoint: Baseline and Week 24;Change in relative mRNA expression levels of IL-23Timepoint: Baseline and Week 24;Association between gene polymorphisms (Cdx2 and Fok1 polymorphisms) and clinical response (more than or equal to 50% reduction in IASI).Timepoint: Week 24 | — |
Countries
India
Contacts
Public ContactDr Rahul Mahajan
Post Graduate Institute of Medical Education and Research
Outcome results
None listed