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

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

Study Type: Interventional

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

Study Primary Completion Date: June 2007

Same as above.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • More frequent than normal office visits
• Active Comparator: 2
  • Electronic reminders (voice, e-mail, text messages)
• Active Comparator: 3
  • Parental involvement / intervention reminders
• Active Comparator: 4
  • No intervention or reminders

Primary Measures

• Efficacy - Percent adherence calculated from MEMS Caps readings
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary 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
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety - tolerability and adverse event reporting
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437151

Study ID Number: US10022

ClinicalTrials.gov Identifier: NCT00437151

Health Authority: United States: Institutional Review Board