A Novel Method to Improve Acne Outcomes

Wake Forest University (WFU)

Status: Completed

Conditions: Acne Vulgaris

Treatments: Behavioral: Internet survey; Drug: Benzoyl peroxide 5% gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01176955

IRB00008982

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Internet survey

Experimental group

Description:

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

Treatment:

Drug: Benzoyl peroxide 5% gel

Behavioral: Internet survey

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Benzoyl peroxide 5% gel