Topical Roflumilast in Adults With Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 0.5% Roflumilast Cream — DRUG
  Roflumilast 0.5% cream
• Vehicle Cream — DRUG
  Roflumilast formulation vehicle

Study Details

The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.

Key Dates

Start date

Jun 30, 2013

Status verified

Sep 2016

Primary completion

Mar 31, 2014

Completion

Mar 31, 2014

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 0.5% Roflumilast Cream
  Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
• Placebo Comparator: Vehicle Cream
  Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.

Primary Outcome Measure

Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline and Day 15 ]

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