Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne|
- Adherence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Benzoyl Peroxide 5%
Drug: Benzoyl Peroxide
Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a container that records when the container is opened and closed. Subjects will simply be asked to "return in six weeks to see how well benzoyl peroxide works for them." Subjects initially will not be told that they are participating in a formal study. When they return with their medication, we will seek their informed consent to participate in the study. Verbal consent will be obtained at the beginning of the study. There will be no written consent obtained until the end of the study. By doing this, subjects will not be aware that adherence is being measured. Subjects will not be aware that they are participating in a study. Only if they consent would we then collect the medication container and monitor and retrieve the adherence data. If they do not consent, we will not have collected any research data on them except baseline acne severity measures which may have been collected anyway as part of their clinic treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658112
|United States, North Carolina|
|Wake Forest University Health Sciences Dermatology|
|Winston Salem, North Carolina, United States, 27157|
|Principal Investigator:||Steven R Feldman, MD||Wake Forest School of Medicine|