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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01014689
First received: November 16, 2009
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Adapalene/ BPO gel with Lymecycline capsules
Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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 Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Percent Change From Baseline in Total Lesion Count [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.


Secondary Outcome Measures:
  • Success Rate on the Investigator's Global Assessment (IGA) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 378
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Adapalene/BPO vehicle with Lymecycline

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01014689

Locations
Australia
Galderma Investigator site
Camberra, Australia
Galderma Investigator site
Kogarah, Australia
Galderma Investigator site
Melbourne, Australia
Galderma Investigator site
Sydney, Australia
Belgium
Galderma Investigator site
Bruxelles, Belgium
Galderma Investigator site
Gent, Belgium
Galderma Investigator site
Leuven, Belgium
Brazil
Galderma Investigator site
Belo Horizonte, Brazil
Galderma Investigator site
Sao Paulo, Brazil
France
Galderma Investigator site
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
Germany
Galderma Investigator site
Cuxhaven, Germany
Galderma Investigator site
Darmstadt, Germany
Galderma Investigator site
Frankfurt, Germany
Italy
Galderma Investigator site
Catania, Italy
Galderma Investigator site
Ferrara, Italy
Mexico
Galderma Investigator site
Mexico city, Mexico
Galderma Investigator site
Monterrey, Mexico
Galderma Investigator site
Tlalnepantla, Mexico
Galderma Investigator site
Zapopan, Mexico
Poland
Galderma Investigator site
Lodz, Poland
Sweden
Galderma Investigator site
Eskilstuna, Sweden
Galderma Investigator site
Farsta, Sweden
Galderma Investigator site
Hagersten, Sweden
Sponsors and Collaborators
Galderma
Investigators
Study Director: Florence Paliargues Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014689     History of Changes
Other Study ID Numbers: RD.03.SPR.29080
Study First Received: November 16, 2009
Results First Received: August 12, 2011
Last Updated: April 17, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Sweden: Institutional Review Board
Sweden: Swedish Research Council
Poland: Ethics Committee
Poland: Ministry of Health
Italy: Ethics Committee
Italy: Ministry of Health
Brazil: Ethics Committee
Brazil: Ministry of Health
Mexico: Ethics Committee
Mexico: Ministry of Health
Germany: Ethics Commission
Germany: Ministry of Health

Keywords provided by Galderma:
acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Lymecycline
Adapalene
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014