CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 378 enrolled
Drug / intervention
Adapalene/ BPO gel with Lymecycline capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01014689
NCT01014689Phase 3Completed
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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

Galderma R&D·interventional·Posted Nov 17, 2009·Updated Feb 18, 2021

In Brief

A Phase 3 clinical trial evaluating Adapalene/ BPO gel with Lymecycline capsules and Adapalene/ BPO vehicle gel with Lymecycline capsules for Acne Vulgaris. Completed, enrolled 378 participants across 28 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesAustralia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 years ago

Interventions

Adapalene/ BPO gel with Lymecycline capsulesdrug

Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Adapalene/ BPO vehicle gel with Lymecycline capsulesdrug

Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning