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NCT01014689: TEAM

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

Completed Phase 3 Results posted Last updated 16 February 2021
What this trial tests

Phase 3 trial testing Adapalene/ BPO gel with Lymecycline capsules in Acne Vulgaris in 378 participants. Completed in 1 May 2010.

Timeline
1 August 2009
Primary endpoint
1 April 2010
1 May 2010

Quick facts

Lead sponsorGalderma R&D
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment378
Start date1 August 2009
Primary completion1 April 2010
Estimated completion1 May 2010
Sites28 locations across Australia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 12 to 35, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Topical benzoyl peroxide for acne.
    Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2

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Other recruiting trials for Acne Vulgaris

Currently open trials in the same condition.

Other Galderma R&D trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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