Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Astion Pharma A/S300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Seborrheic Dermatitis

Interventions

ASF1057DRUG

Twice daily, topical

ASF1057DRUG

Twice daily, Topical

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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