NCT01014689

Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

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 Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene/ BPO gel with Lymecycline capsules	Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
DRUG	Adapalene/ BPO vehicle gel with Lymecycline capsules	Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-11-17
• Last updated: 2021-02-18
• Results posted: 2012-04-05

Locations

28 sites across 9 countries: Australia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland, Sweden