A Study to Assess Safety of Tofacitinib Ointment in Mild to Moderate Eczema Patients.
Phase 4
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2023/11/059941
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Male and female patients, with age = 18 years, willing to give voluntary informed consent
2.Have a clinical diagnosis of atopic dermatitis(AD) according to the criteria of Hanifin and Rajka
3.Patients with mild to moderate AD based on vIGA-AD score of 2 (mild) or 3 (moderate) at Baseline
4.Have involvement of = 5% treatable body surface area (BSA) (excluding the scalp) and up to and including 20% of total BSA at Day 1 using Mostellar formulae
5.Eligible patient prescribed tofacitinib 2% w/w ointment, in usual course of treatment as per PI discretion
Exclusion Criteria
1.Having no contraindications as mentioned in prescribing information
2.Any other condition where PI assesses that patient is not eligible for participation in the study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of adverse events (AE) and serious adverse events (SAE) <br/ ><br>2. Local TolerabilityTimepoint: Baseline, Week 4 week 8 and week 12
- Secondary Outcome Measures
Name Time Method Change in patient assessment of Pruritus using numerical scale from baselineTimepoint: week 4 week 8 and week 12;Percentage of participants achieving validated investigator global assessment of 0 or 1 with greater than or equal to 2 points improvement from baselineTimepoint: Week 4 week 8 and week 12