Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
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|ClinicalTrials.gov Identifier: NCT00031096|
Recruitment Status : Completed
First Posted : February 22, 2002
Last Update Posted : April 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251) Drug: Vehicle gel (SH H 655 PBA)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||879 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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.|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||July 2002|
|Actual Study Completion Date :||July 2002|
|Experimental: Arm 1||
Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
|Placebo Comparator: Arm 2||
Drug: Vehicle gel (SH H 655 PBA)
Vehicle gel (SH H 655 PBA) applied topically two times per day.
- 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 [ Time Frame: 12 weeks ]
- Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability [ Time Frame: 12 weeks ]
- Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031096
|United States, Alabama|
|Mobile, Alabama, United States, 36608|
|United States, Colorado|
|Boulder, Colorado, United States, 80304|
|United States, Georgia|
|Newnan, Georgia, United States, 30263|
|United States, Kansas|
|Shawnee Mission, Kansas, United States, 66203|
|Wichita, Kansas, United States, 67206|
|United States, Kentucky|
|Lexington, Kentucky, United States, 40509|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, New York|
|Bay Shore, New York, United States, 11706|
|United States, North Carolina|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45230|
|United States, Oregon|
|Portland, Oregon, United States, 97223-6683|
|United States, Pennsylvania|
|Hershey, Pennsylvania, United States, 17033|
|United States, Tennessee|
|Knoxville, Tennessee, United States, 37922|
|United States, Texas|
|Bryan, Texas, United States, 77802|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|Seattle, Washington, United States, 98105|
|Study Director:||Bayer Study Director||Bayer|