Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 29, 2022
March 1, 2008
1 year
February 16, 2007
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy - Percent adherence calculated from MEMS Caps readings
12 weeks
Secondary Outcomes (2)
Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
12 weeks
Safety - tolerability and adverse event reporting
12 weeks
Study Arms (4)
1
ACTIVE COMPARATORMore frequent than normal office visits
2
ACTIVE COMPARATORElectronic reminders (voice, e-mail, text messages)
3
ACTIVE COMPARATORParental involvement / intervention reminders
4
ACTIVE COMPARATORNo intervention or reminders
Interventions
Eligibility Criteria
You may qualify if:
- Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald W Gottschalk, MD
Galderma Laboratories, LP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
June 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
July 29, 2022
Record last verified: 2008-03