A Novel Method to Improve Acne Outcomes - Full Text View

Purpose

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	Intervention
Acne Vulgaris	Behavioral: Internet survey Drug: Benzoyl peroxide 5% gel

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Novel Method for Improving Acne Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

Adherence to Study Medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported.

Secondary Outcome Measures:

The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
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.
The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
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.
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps.
The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.

Enrollment:	20
Study Start Date:	May 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176955

Locations

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

Investigators

Study Director:

Steven R Feldman, MD, PhD

Wake Forest University

More Information

No publications provided

Responsible Party:	Steven R. Feldman, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier:	NCT01176955 History of Changes
Other Study ID Numbers:	8982
Study First Received:	August 5, 2010
Results First Received:	July 1, 2011
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

Acne
Acne vulgaris
Adherence

Compliance
MEMS
Benzoyl peroxide

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013