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Clinical Trial 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 plaque psoriasis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a 4-week treatment period 76 mg cream is applied two times daily on up to 2% 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 anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00746434
Study type Interventional
Source AstraZeneca
Contact
Status Withdrawn
Phase Phase 2
Start date November 2008
Completion date September 2009

See also
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