Clinical Trial: Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate

Brief Summary: The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.

Detailed Summary:
Sponsor: Wake Forest University

Current Primary Outcome: Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne [ Time Frame: 12 weeks ]

Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap


Original Primary Outcome: Measured adherence to ZIANA Gel or generic topical clindamycin 1% gel each morning plus generic topical tretinoin 0.025% cream each evening in subjects with mild to moderate acne via a MEMS cap. [ Time Frame: 12 weeks ]

Current Secondary Outcome: The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ]

Original Secondary Outcome: The change (dynamic assessment) from Baseline to Week 12 (or end of treatment) in the Investigator Global Assessment of acne. [ Time Frame: 12 weeks ]

Information By: Wake Forest University Health Sciences

Dates:
Date Received: January 11, 2010
Date Started: March 2009
Date Completion:
Last Updated: January 24, 2017
Last Verified: November 2011