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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adapalene/ BPO gel with Lymecycline capsules
Adapalene/ BPO vehicle gel with Lymecycline capsules
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site
  • Galderma Investigator site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adapalene 0.1% / BPO 2.5% gel

Adapalene 0.1% / BPO 2.5% Vehicle Gel

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Total Lesion Count
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
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.

Full Information

First Posted
November 16, 2009
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01014689
Brief Title
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Acronym
TEAM
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene 0.1% / BPO 2.5% gel
Arm Type
Active Comparator
Arm Title
Adapalene 0.1% / BPO 2.5% Vehicle Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adapalene/ BPO gel with Lymecycline capsules
Other Intervention Name(s)
Adapalene/BPO with Lymecycline
Intervention Description
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Adapalene/ BPO vehicle gel with Lymecycline capsules
Other Intervention Name(s)
Adapalene/BPO vehicle with Lymecycline
Intervention Description
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total Lesion Count
Description
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Success Rate on the Investigator's Global Assessment (IGA) at Week 12
Description
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.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive, Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4), Exclusion Criteria: Subjects with more than 3 nodules or cysts on the face Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 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) 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) 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, Subjects with known intolerance to lactose,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Paliargues
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Galderma Investigator site
City
Camberra
Country
Australia
Facility Name
Galderma Investigator site
City
Kogarah
Country
Australia
Facility Name
Galderma Investigator site
City
Melbourne
Country
Australia
Facility Name
Galderma Investigator site
City
Sydney
Country
Australia
Facility Name
Galderma Investigator site
City
Bruxelles
Country
Belgium
Facility Name
Galderma Investigator site
City
Gent
Country
Belgium
Facility Name
Galderma Investigator site
City
Leuven
Country
Belgium
Facility Name
Galderma Investigator site
City
Belo Horizonte
Country
Brazil
Facility Name
Galderma Investigator site
City
Sao Paulo
Country
Brazil
Facility Name
Galderma Investigator site
City
Bordeaux
Country
France
Facility Name
Galderma Investigator site
City
Cannes
Country
France
Facility Name
Galderma Investigator site
City
Martigues
Country
France
Facility Name
Galderma Investigator site
City
Nantes
Country
France
Facility Name
Galderma Investigator site
City
Pantin
Country
France
Facility Name
Galderma Investigator site
City
Pierre Benite
Country
France
Facility Name
Galderma Investigator site
City
Cuxhaven
Country
Germany
Facility Name
Galderma Investigator site
City
Darmstadt
Country
Germany
Facility Name
Galderma Investigator site
City
Frankfurt
Country
Germany
Facility Name
Galderma Investigator site
City
Catania
Country
Italy
Facility Name
Galderma Investigator site
City
Ferrara
Country
Italy
Facility Name
Galderma Investigator site
City
Mexico city
Country
Mexico
Facility Name
Galderma Investigator site
City
Monterrey
Country
Mexico
Facility Name
Galderma Investigator site
City
Tlalnepantla
Country
Mexico
Facility Name
Galderma Investigator site
City
Zapopan
Country
Mexico
Facility Name
Galderma Investigator site
City
Lodz
Country
Poland
Facility Name
Galderma Investigator site
City
Eskilstuna
Country
Sweden
Facility Name
Galderma Investigator site
City
Farsta
Country
Sweden
Facility Name
Galderma Investigator site
City
Hagersten
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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