NCT00031096

Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 879 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Acne is a common inflammatory skin condition characterized by skin eruptions around hair follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders, but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the safety and effectiveness of an investigational gel containing active medication compared to the same gel without any active medication (placebo or vehicle) in subjects with mild to moderate facial acne. This study has initially been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Intendis Inc., a Bayer HealthCare company, is the sponsor of the trial.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Azelaic Acid Gel 15% (Finacea, BAY39-6251)	Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
DRUG	Vehicle gel (SH H 655 PBA)	Vehicle gel (SH H 655 PBA) applied topically two times per day.

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-07-01
• Completion: 2002-07-01
• First posted: 2002-02-22
• Last updated: 2023-06-09

Locations

16 sites across 1 country: United States