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

Galderma R&D1 site in 1 country61 target enrollmentJune 2006

ConditionsAcne

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Acne
Sponsor: Galderma R&D
Enrollment: 61
Locations: 1
Primary Endpoint: Efficacy - Percent adherence calculated from MEMS Caps readings
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

June 2007

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Galderma R&D

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)

Outcomes

Primary Outcomes

Efficacy - Percent adherence calculated from MEMS Caps readings

Time Frame: 12 weeks

Secondary Outcomes

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)