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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
879
Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
Vehicle gel (SH H 655 PBA) applied topically two times per day.
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Boulder, Colorado, United States
Unnamed facility
Newnan, Georgia, United States
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
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Unnamed facility
Shawnee Mission, Kansas, United States
Unnamed facility
Wichita, Kansas, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Bay Shore, New York, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
...and 6 more locations