Clinical Trial: A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate
Brief Summary: The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: The sum score derived from the most important signs and symptoms of perioral dermatitis [ Time Frame: Measurements and observations during the course of the study ]
Original Primary Outcome: The sum score derived from the most important signs and symptoms of perioral dermatitis
Current Secondary Outcome:
- Intensity of single signs and symptoms [ Time Frame: Measured at scheduled visits during the course of the study ]
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator [ Time Frame: Safety parameters recorded at scheduled visits during the course of the study ]
Original Secondary Outcome:
- Intensity of single signs and symptoms
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
Information By: Bayer
Dates:
Date Received: November 23, 2006
Date Started: November 2006
Date Completion:
Last Updated: February 15, 2015
Last Verified: February 2015
