Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
July 30, 2018 updated by: Wake Forest University
The purpose of this research study is to see how often benzoyl peroxide is applied for acne.
Use of medication was monitored electronically.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist will be eligible for participation.
- Verbal consent of participation must be given by parent or guardian and child.
Exclusion Criteria:
- Age less than 13 or greater than 18 years of age.
- Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
- Subjects should not be using topical retinoids or benzoyl peroxide products, including Proactive® or topical prescription medications for the treatment of acne vulgaris for at least 2 weeks prior to beginning the study. Oral medications for the treatment of acne should not have been used at least 4 weeks prior to beginning the study.
- Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Benzoyl Peroxide 5%
Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap.
This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software.
When the tubes are weighed, data from the MEMS Caps will be collected.
Study coordinators will record adherence, while assessors are blinded to adherence rates.
All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
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Benzoyl peroxide 5% gel.
Applied once daily to face, minimum amount usable to cover area.
Every day for six weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 6 weeks
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Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven R Feldman, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
April 9, 2008
First Submitted That Met QC Criteria
April 9, 2008
First Posted (Estimate)
April 14, 2008
Study Record Updates
Last Update Posted (Actual)
August 28, 2018
Last Update Submitted That Met QC Criteria
July 30, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0000027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.