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Completed

NCT Number: NCT00658112

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

The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benzoyl peroxide

Drug

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

Other names: Epiduo

Primary outcomes

  1. Adherence

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 14, 2008
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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