Back to resultsAnalysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
More frequent than normal office visits
Electronic reminders (voice, e-mail, text messages)
Parenteral involvement / intervention reminders
No intervention or reminders
Sponsored by
About this trial
This is an interventional treatment trial for Acne
Eligibility Criteria
Inclusion Criteria:
- Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
Exclusion Criteria:
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
More frequent than normal office visits
Electronic reminders (voice, e-mail, text messages)
Parental involvement / intervention reminders
No intervention or reminders
Outcomes
Primary Outcome Measures
Efficacy - Percent adherence calculated from MEMS Caps readings
Secondary Outcome Measures
Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
Safety - tolerability and adverse event reporting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437151
Brief Title
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
Official Title
An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.
Detailed Description
Same as above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
More frequent than normal office visits
Arm Title
2
Arm Type
Active Comparator
Arm Description
Electronic reminders (voice, e-mail, text messages)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Parental involvement / intervention reminders
Arm Title
4
Arm Type
Active Comparator
Arm Description
No intervention or reminders
Intervention Type
Other
Intervention Name(s)
More frequent than normal office visits
Intervention Description
Mode of patient reminder
Intervention Type
Other
Intervention Name(s)
Electronic reminders (voice, e-mail, text messages)
Intervention Description
Mode of patient reminder
Intervention Type
Other
Intervention Name(s)
Parenteral involvement / intervention reminders
Intervention Description
Mode of patient reminder
Intervention Type
Other
Intervention Name(s)
No intervention or reminders
Intervention Description
Mode of patient reminder
Primary Outcome Measure Information:
Title
Efficacy - Percent adherence calculated from MEMS Caps readings
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
Time Frame
12 weeks
Title
Safety - tolerability and adverse event reporting
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:
Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
Exclusion Criteria:
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma Laboratories, LP
Official's Role
Study Director
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
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