Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib Ointment 2% w/w: Tofacitinib Ointment (above 3 mg/cm ) should be applied to the affected area (upto 20% of
body surface area) of the skin twice daily
Control Intervention1:
Sponsors
Lyka Labs Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients, with age of 18 years and above, having flare up of disease, voluntarily willing to give 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 patients prescribed Tofacitinib 2% w/w ointment, in usual course of treatment for patients having flare up of disease 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 |
|---|---|
| To establish the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)Timepoint: baseline (Visit 1), week 2 (Visit 2), week 4(Visit 3), end of the study week 6 (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of participants achieving validated Investigator Global Assessment of 0 or 1 with greater than or equal to 2 points improvement 2. Change in patient assessment of vIGA and EASI using numerical scaleTimepoint: baseline (Visit 1), week 2 (Visit 2), week 4(Visit 3), end of the study week 6(Visit 4) | — |
Countries
India
Contacts
Public ContactDr Viral Shah
Lyka Labs Private Limited
Outcome results
None listed