Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01188538
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : July 7, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 25, 2010
Results First Submitted Date  ICMJE June 9, 2011
Results First Posted Date  ICMJE July 7, 2011
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes [ Time Frame: Week 12 ]
Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
Percent change in P. acnes count [ Time Frame: Week 2, Week 6, Week 12 ]
Change History Complete list of historical versions of study NCT01188538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
Percent Change (%) in Inflammatory Lesion Counts [ Time Frame: Week 12 ]
Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
Percent change in total lesion counts [ Time Frame: Week 2, Week 6, Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
Official Title  ICMJE Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris
Brief Summary The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Epiduo gel
    Once daily application on the face in the evening for 12 weeks
    Other Name: Epiduo
  • Drug: BPO
    Once daily application on the face in the evening for 12 weeks
Study Arms  ICMJE
  • Experimental: Epiduo gel
    • Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel.
    • Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
    • Duration of Treatment:12 weeks
    Intervention: Drug: Epiduo gel
  • Active Comparator: BPO gel
    • Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel.
    • Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
    • Duration of Treatment:12 weeks
    Intervention: Drug: BPO
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: August 24, 2010)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with facial acne,
  • Subjects with high levels of P. acnes counts on the forehead

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
  • Subjects with acne conglobata, acne fulminans, secondary acne
  • Subjects with known or suspected allergy to one of the test product
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188538
Other Study ID Numbers  ICMJE RD.03.SPR.29084
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
Principal Investigator: Andrzej LANGNER, Professor Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND
PRS Account Galderma
Verification Date July 2011

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