Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris (TEAM)

February 16, 2021 updated by: Galderma R&D

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camberra, Australia
        • Galderma Investigator site
      • Kogarah, Australia
        • Galderma Investigator site
      • Melbourne, Australia
        • Galderma Investigator site
      • Sydney, Australia
        • Galderma Investigator site
  • Belgium
      • Bruxelles, Belgium
        • Galderma Investigator site
      • Gent, Belgium
        • Galderma Investigator site
      • Leuven, Belgium
        • Galderma Investigator site
  • Brazil
      • Belo Horizonte, Brazil
        • Galderma Investigator site
      • Sao Paulo, Brazil
        • Galderma Investigator site
  • France
      • Bordeaux, France
        • Galderma Investigator site
      • Cannes, France
        • Galderma Investigator site
      • Martigues, France
        • Galderma Investigator site
      • Nantes, France
        • Galderma Investigator site
      • Pantin, France
        • Galderma Investigator site
      • Pierre Benite, France
        • Galderma Investigator site
  • Germany
      • Cuxhaven, Germany
        • Galderma Investigator site
      • Darmstadt, Germany
        • Galderma Investigator site
      • Frankfurt, Germany
        • Galderma Investigator site
  • Italy
      • Catania, Italy
        • Galderma Investigator site
      • Ferrara, Italy
        • Galderma Investigator site
  • Mexico
      • Mexico city, Mexico
        • Galderma Investigator site
      • Monterrey, Mexico
        • Galderma Investigator site
      • Tlalnepantla, Mexico
        • Galderma Investigator site
      • Zapopan, Mexico
        • Galderma Investigator site
  • Poland
      • Lodz, Poland
        • Galderma Investigator site
  • Sweden
      • Eskilstuna, Sweden
        • Galderma Investigator site
      • Farsta, Sweden
        • Galderma Investigator site
      • Hagersten, Sweden
        • Galderma Investigator site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 31 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female Subjects of any race, aged 12 to 35 years inclusive,
  2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Exclusion Criteria:

  1. Subjects with more than 3 nodules or cysts on the face
  2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
  3. Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
  4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
  5. Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
  6. Subjects with known intolerance to lactose,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adapalene 0.1% / BPO 2.5% gel
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
Other Names:
  • Adapalene/BPO with Lymecycline
Placebo Comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel
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
Other Names:
  • Adapalene/BPO vehicle with Lymecycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Lesion Count
Time Frame: Baseline and Week 12
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Time Frame: Baseline and Week 12
Percentage of Subjects "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Study Director: Florence Paliargues, Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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