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

Condition(s) targeted: Acne

Intervention: More frequent than normal office visits (Other); Electronic reminders (voice, e-mail, text messages) (Other); Parenteral involvement / intervention reminders (Other); No intervention or reminders (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, LP

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

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment

Primary outcome: Efficacy - Percent adherence calculated from MEMS Caps readings

Secondary outcome:

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

Detailed description: Same as above.

Minimum age: 13 Years. Maximum age: 18 Years. Gender(s): Both.

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)

Wake Forest School of Medicine, Winston-Salem, North Carolina 27157, United States

Starting date: June 2006
Ending date: June 2007
Last updated: March 27, 2008