A Novel Method to Improve Acne Outcomes

NCT ID: NCT01176955

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-08-31

Brief Summary

This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internet survey

Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.

Group Type: EXPERIMENTAL

Internet survey

Intervention Type: BEHAVIORAL

A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.

Benzoyl peroxide 5% gel

Intervention Type: DRUG

Topical benzoyl peroxide 5% gel, to be used once daily to the face.

Control

Subjects will receive standard-of-care treatment with the study medication, without internet surveys.

Group Type: PLACEBO_COMPARATOR

Benzoyl peroxide 5% gel

Intervention Type: DRUG

Topical benzoyl peroxide 5% gel, to be used once daily to the face.

Interventions

Internet survey

A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.

Intervention Type: BEHAVIORAL

Benzoyl peroxide 5% gel

Topical benzoyl peroxide 5% gel, to be used once daily to the face.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
• written 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 may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in 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.
• Subjects will be carefully selected for this study and only those deemed appropriate for treatment with benzoyl peroxide will be placed on this medication.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Feldman, MD, PhD

Role: STUDY_DIRECTOR

Wake Forest University

Locations

Wake Forest University Health Sciences, Department of Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00008982

Identifier Type: -

Identifier Source: org_study_id