A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.

NCT00031096 Phase 3 COMPLETED

Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.

Details

Lead sponsor	LEO Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	879
Start date	2002-01
Completion	2002-07

Conditions

• Acne Vulgaris

Interventions

• Azelaic Acid Gel 15% (Finacea, BAY39-6251)
• Vehicle gel (SH H 655 PBA)

Primary outcomes

• The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne — 12 weeks

Countries

United States