Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Sponsor
Pfizer
Study ID
NCT02001181
Phase
PHASE2
Status
Completed

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib ointment 20mg/g — DRUG
    Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
  • Placebo ointment (Vehicle) — DRUG
    Placebo ointment (vehicle) twice daily (BID) for 4 weeks

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
Sep 2015
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
  • Placebo Comparator: Treatment B

Primary Outcome Measure

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 [ Time Frame: Baseline (pre-dose on Day 1) and Week 4 ]

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