NCT00746382

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

A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dermatitis

Interventions

Type	Name	Description
DRUG	Roflumilast cream	Roflumilast cream 0.5% versus Placebo cream
DRUG	Placebo cream	Placebo cream

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-06-01
• Completion: 2009-09-01
• First posted: 2008-09-04
• Last updated: 2016-12-01