A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis
Status:
Withdrawn
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
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.