Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00565279

Enrollment

300

Registered

2007-11-29

Start date

2007-12-31

Completion date

2008-06-30

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Dermatitis

Keywords

Seborrhoeic dermatitis

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.

Interventions

DRUGASF1057

Twice daily, topical

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026