Clinical Trial: Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of ASF 1057 Cream 0.5% in the Treatment of Seborrhoeic Dermatitis: A Phase III Randomised, Double-Blind, Vehicle and Placebo Controlled, Parallel Group

Brief Summary: A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis.

Detailed Summary:
Sponsor: Astion Pharma A/S

Current Primary Outcome: Proportion of responders, defined as patients with OSS ≤ 1 score units. [ Time Frame: Baseline, day 7, day 14, and day 21 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Astion Pharma A/S

Dates:
Date Received: November 28, 2007
Date Started: December 2007
Date Completion:
Last Updated: June 2, 2008
Last Verified: June 2008