Back to resultsAnti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Epiduo gel
BPO
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring P. acnes, Acne vulgaris
Eligibility 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
Sites / Locations
- Dermatologiczna Klinika Uzdrowiskowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epiduo gel
BPO gel
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188538
Brief Title
Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
P. acnes, Acne vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epiduo gel
Arm Type
Experimental
Arm Description
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
Arm Title
BPO gel
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Epiduo gel
Other Intervention Name(s)
Epiduo
Intervention Description
Once daily application on the face in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
BPO
Intervention Description
Once daily application on the face in the evening for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change (%) in Inflammatory Lesion Counts
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej LANGNER, Professor
Organizational Affiliation
Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatologiczna Klinika Uzdrowiskowa
City
Iwonicz Zdrój
ZIP/Postal Code
38-440
Country
Poland
12. IPD Sharing Statement
Links:
URL
http://www.galderma.com
Description
Related Info
Learn more about this trial
Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
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