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

NCT00658112 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB0000027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Adherence

  Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied

  6 weeks

Study Arms (1)

Benzoyl Peroxide 5%

EXPERIMENTAL

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

Interventions

Benzoyl Peroxide DRUG

Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

Also known as: Epiduo

Benzoyl Peroxide 5%

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl Peroxide; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adapalene; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Steve Feldman MD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Steven R Feldman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: July 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 28, 2018
• Results First Posted: March 17, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)