A Novel Method to Improve Acne Outcomes

Acne Vulgaris Clinical Trial

Official title:

A Novel Method for Improving Acne Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176955
• Other study ID #: IRB00008982
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences, Department of Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.	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
Secondary	The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.	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
Secondary	The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.	All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.	12 weeks