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Completed

NCT Number: NCT01176955

A Novel Method to Improve Acne Outcomes

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences, Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Internet Survey

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

Drug

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

Primary outcomes

  1. The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.

    Time frame: 12 weeks

    Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.

Secondary outcomes

  1. The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.

    Time frame: Baseline to 12 weeks

    Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.

  2. The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.

    Time frame: Baseline to 12 weeks

    Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.

  3. The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.

    Time frame: 12 weeks

    All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

A Novel Method for Improving Acne Outcomes

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2010
Registry last updated
Aug 16, 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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