Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib Ointment 2% w/w as usual course of treatment: Twice daily to all AD affected areas, except those on hair-bearing scalp for 84 days
Control Intervention1: Not Applicable: Not
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events (AE) and serious adverse events (SAE) 2. Local TolerabilityTimepoint: Baseline, Week 4 week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Dhavalkumar Patel
Intas Pharmaceuticals Limited
Outcome results
None listed