We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Novel Method to Improve Acne Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01176955
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : October 21, 2011
Last Update Posted : August 16, 2018
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Behavioral: Internet survey Drug: Benzoyl peroxide 5% gel Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Novel Method for Improving Acne Outcomes
Study Start Date : May 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176955

Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Layout table for investigator information
Study Director: Steven R Feldman, MD, PhD Wake Forest University
Layout table for additonal information
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01176955    
Other Study ID Numbers: IRB00008982
First Posted: August 6, 2010    Key Record Dates
Results First Posted: October 21, 2011
Last Update Posted: August 16, 2018
Last Verified: June 2018
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Acne vulgaris
Benzoyl peroxide
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents