Phase 2
Completed N=69
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT02001181 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 — -81.7; -29.9 percent change — p=<0.0001
Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 |
-81.7; -29.9 | <0.0001 sig |
| SECONDARY Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4 |
71.4; 20.6 | — |
| SECONDARY Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4 |
65.7; 11.8 | — |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4 |
-72.7; -30.2 | — |
| SECONDARY Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4 |
-11.4; -4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
- Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).
Exclusion Criteria
- Evidence of certain skin conditions/infections at baseline
- Currently have atopic dermatitis on groin, genitals, palm or soles
- Have certain laboratory abnormalities at baseline
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Data sourced from ClinicalTrials.gov (NCT02001181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.