A Novel Method to Improve Acne Outcomes

NCT01176955 | Completed Results

• 1 other identifier: IRB00008982
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne; Acne vulgaris; Adherence; Compliance; MEMS; Benzoyl peroxide

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

  Baseline to 12 weeks

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

  Baseline to 12 weeks

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

  12 weeks

Study Arms (2)

Internet survey

EXPERIMENTAL

Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.

Behavioral: Internet survey; Drug: Benzoyl peroxide 5% gel

Control

PLACEBO COMPARATOR

Subjects will receive standard-of-care treatment with the study medication, without internet surveys.

Drug: Benzoyl peroxide 5% gel

Interventions

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.

Internet survey

Benzoyl peroxide 5% gel DRUG

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

Control; Internet survey

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences, Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Patient Compliance

Interventions

Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Brad Yentzer
• Organization: Wake Forest Baptist Medical Center

byentzer@wakehealth.edu

336-716-4735

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 16, 2018
• Results First Posted: October 21, 2011

Record last verified: 2018-06

Locations

US (1)