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

Phase 4

Completed

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

• Registration Number: NCT00437151
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-17
• Study First Posted: 2007-02-19
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-03
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Parenteral involvement / intervention reminders	Parental involvement / intervention reminders
2	Electronic reminders (voice, e-mail, text messages)	Electronic reminders (voice, e-mail, text messages)
1	More frequent than normal office visits	More frequent than normal office visits
4	No intervention or reminders	No intervention or reminders

Primary Outcome Measures

Name	Time	Method
Efficacy - Percent adherence calculated from MEMS Caps readings	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States