Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Seborrheic Dermatitis Clinical Trial

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 Groups, Multi-Centre Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565279
• Other study ID #: ASF1057-301
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2007
• Last updated: June 2, 2008
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Astion Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

Drug:
• ASF1057
Twice daily, topical
• ASF1057
Twice daily, Topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astion Pharma A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of responders, defined as patients with OSS = 1 score units.		Baseline, day 7, day 14, and day 21	Yes