Clinical Trial: Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe
Brief Summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.
The safety of the two treatment regimens will also be evaluated.
Detailed Summary:
Sponsor: Galderma
Current Primary Outcome: Percent Change From Baseline in Total Lesion Count [ Time Frame: Baseline and Week 12 ]
Original Primary Outcome:
- Non-Inflammatory Lesions and Inflammatory Lesions, nodules/cysts counts on the face (excluding the nose) [ Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks) ]
- Investigator's Global Assessment: severity of acne on a scale from 0 to 5 [ Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks) ]
Current Secondary Outcome: Success Rate on the Investigator's Global Assessment (IGA) at Week 12 [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome:
Information By: Galderma
Dates:
Date Received: November 16, 2009
Date Started: August 2009
Date Completion:
Last Updated: April 17, 2012
Last Verified: April 2012
