Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

Astion Pharma

Status and phase: Completed; Phase 3

Conditions: Seborrheic Dermatitis

Treatments: Drug: ASF1057

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565279

ASF1057-301

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

ASF1057

Experimental group

Treatment:

Drug: ASF1057

Drug: ASF1057

ASF1057 placebo

Placebo Comparator group

Treatment:

Drug: ASF1057

Drug: ASF1057

ASF1057 Vehicle

Placebo Comparator group

Treatment:

Drug: ASF1057

Drug: ASF1057