A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

Sponsor
AstraZeneca
Study ID
NCT00746382
Phase
PHASE2
Status
Withdrawn

Conditions

  • Dermatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast cream — DRUG
    Roflumilast cream 0.5% versus Placebo cream
  • Placebo cream — DRUG
    Placebo cream

Study Details

The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows.As roflumilast is a potent antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.

Key Dates

Start date
Nov 30, 2008
Status verified
Oct 2016
Primary completion
Jun 30, 2009
Completion
Sep 30, 2009

Study Design

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

Arms

  • Active Comparator: 1
    Roflumilast cream 0.5%
  • Placebo Comparator: 2
    Placebo cream

Primary Outcome Measure

Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity [ Time Frame: 28 days ]

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