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

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ClinicalTrials.gov Identifier: NCT01014689
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : April 5, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE November 16, 2009
First Posted Date  ICMJE November 17, 2009
Results First Submitted Date  ICMJE August 12, 2011
Results First Posted Date  ICMJE April 5, 2012
Last Update Posted Date April 20, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2009)
  • Non-Inflammatory Lesions and Inflammatory Lesions, nodules/cysts counts on the face (excluding the nose) [ Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks) ]
  • Investigator's Global Assessment: severity of acne on a scale from 0 to 5 [ Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks) ]
Change History Complete list of historical versions of study NCT01014689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Adapalene 0.1% / BPO 2.5% gel
    Intervention: Drug: Adapalene/ BPO gel with Lymecycline capsules
  • Placebo Comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel
    Intervention: Drug: Adapalene/ BPO vehicle gel with Lymecycline capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2010)
378
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2009)
360
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   France,   Germany,   Italy,   Mexico,   Poland,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01014689
Other Study ID Numbers  ICMJE RD.03.SPR.29080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Florence Paliargues Galderma
PRS Account Galderma
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP