A Novel Method to Improve Acne Outcomes

August 14, 2018 updated by: Wake Forest University

A Novel Method for Improving 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet survey
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Behavioral: 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.
Drug: Benzoyl peroxide 5% gel
Topical benzoyl peroxide 5% gel, to be used once daily to the face.
Placebo Comparator: Control
Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
Drug: Benzoyl peroxide 5% gel
Topical benzoyl peroxide 5% gel, to be used once daily to the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Investigators

  • Study Director: Steven R Feldman, MD, PhD, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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