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NCT00437151 Clinical Trial

Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%

Acne Clinical Trial

Official title:
An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00437151
Other study ID # US10022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2006
Est. completion date June 2007

Study information
Verified date March 2008
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

Description:

Same as above.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• More frequent than normal office visits
Mode of patient reminder
• Electronic reminders (voice, e-mail, text messages)
Mode of patient reminder
• Parenteral involvement / intervention reminders
Mode of patient reminder
• No intervention or reminders
Mode of patient reminder

Locations
Country Name City State
United States Wake Forest School of Medicine Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy - Percent adherence calculated from MEMS Caps readings 12 weeks
Secondary 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
Secondary Safety - tolerability and adverse event reporting 12 weeks
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