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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT01188538
First received: August 24, 2010
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Drug: Epiduo gel
Drug: BPO
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Percent Change (%) in Inflammatory Lesion Counts [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Epiduo gel
Once daily application on the face in the evening for 12 weeks
Other Name: Epiduo
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
 Drug: BPO
Once daily application on the face in the evening for 12 weeks
Other Name: BPO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188538

Locations
Poland
Dermatologiczna Klinika Uzdrowiskowa
Iwonicz Zdrój, Poland, 38-440
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Andrzej LANGNER, Professor Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Farzaneh SIDOU Clinical Project Manager, Galderma
ClinicalTrials.gov Identifier: NCT01188538     History of Changes
Other Study ID Numbers: RD.03.SPR.29084
Study First Received: August 24, 2010
Results First Received: June 9, 2011
Last Updated: July 13, 2011
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Galderma:
P. acnes, Acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
 Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013