Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Phase 3

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: ASF1057

• Registration Number: NCT00565279
• Lead Sponsor: Astion Pharma A/S

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 Description

Not available

Study Timeline

• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Study Start: 2007-12
• Primary Completion: 2008-05
• Status Verified: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-02
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of moderate to severe seborrhoeic dermatitis

Exclusion Criteria

• Other active skin diseases
• Use of certain systemic and topical treatments
• Extensive sun exposure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASF1057	ASF1057	-
ASF1057 placebo	ASF1057	-
ASF1057 Vehicle	ASF1057	-

Primary Outcome Measures

Name	Time	Method
Proportion of responders, defined as patients with OSS ≤ 1 score units.	Baseline, day 7, day 14, and day 21