Back to resultsMeasuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benzoyl Peroxide
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
- Wake Forest University Health Sciences Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Benzoyl Peroxide 5%
Arm Description
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.
Outcomes
Primary Outcome Measures
Adherence
Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00658112
Brief Title
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Official Title
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Benzoyl Peroxide 5%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Benzoyl Peroxide
Other Intervention Name(s)
Epiduo
Intervention Description
Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Primary Outcome Measure Information:
Title
Adherence
Description
Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
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