Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

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.

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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASF1057

Drug

Twice daily, topical

Primary outcomes

Proportion of responders, defined as patients with OSS ≤ 1 score units.

Time frame: Baseline, day 7, day 14, and day 21

Sponsors and collaborators

Lead sponsor

Astion Pharma A/S

Industry

Registry information

Official study 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.

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Nov 29, 2007
Registry last updated: Jun 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed