Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
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ClinicalTrials.gov Identifier: NCT00658112 |
Recruitment Status :
Completed
First Posted : April 14, 2008
Results First Posted : March 17, 2017
Last Update Posted : August 28, 2018
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Condition or disease | Intervention/treatment | Phase |
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Acne Vulgaris | Drug: Benzoyl Peroxide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |

Arm | Intervention/treatment |
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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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Drug: Benzoyl Peroxide
Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Other Name: Epiduo |
- Adherence [ Time Frame: 6 weeks ]Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied

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Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): 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 University Health Sciences |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00658112 |
Other Study ID Numbers: |
IRB0000027 |
First Posted: | April 14, 2008 Key Record Dates |
Results First Posted: | March 17, 2017 |
Last Update Posted: | August 28, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acne Vulgaris Acneiform Eruptions Skin Diseases |
Sebaceous Gland Diseases Benzoyl Peroxide Dermatologic Agents |