Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne

• ClinicalTrials.gov Identifier: NCT00658112
• Recruitment Status: Completed
• First Posted: April 14, 2008
• Results First Posted: March 17, 2017
• Last Update Posted: August 28, 2018
• Sponsor: Wake Forest University
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Benzoyl Peroxide	Phase 4

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 Design

• 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

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures :

1. Adherence [ Time Frame: 6 weeks ]
   Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

• Principal Investigator: Steven R Feldman, MD; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT00658112
• Other Study ID Numbers: IRB0000027
• First Posted: April 14, 2008
• 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

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Benzoyl Peroxide; Dermatologic Agents