Back to resultsA Novel Method to Improve Acne Outcomes
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet survey
Benzoyl peroxide 5% gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Acne vulgaris, Adherence, Compliance, MEMS, Benzoyl peroxide
Eligibility 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.
Sites / Locations
- Wake Forest University Health Sciences, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Internet survey
Control
Arm Description
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01176955
Brief Title
A Novel Method to Improve Acne Outcomes
Official Title
A Novel Method for Improving Acne Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Acne vulgaris, Adherence, Compliance, MEMS, Benzoyl peroxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet survey
Arm Type
Experimental
Arm Description
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
Intervention Type
Behavioral
Intervention Name(s)
Internet survey
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide 5% gel
Intervention Description
Topical benzoyl peroxide 5% gel, to be used once daily to the face.
Primary Outcome Measure Information:
Title
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.
Description
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.
Time Frame
Baseline to 12 weeks
Title
The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.
Description
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.
Time Frame
Baseline to 12 weeks
Title
The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.
Description
All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Study Director
Facility Information:
Facility Name
Wake Forest University Health Sciences, Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Novel Method to Improve Acne Outcomes
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