Back to resultsEvaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Primary Purpose
P Acnes Colonization
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Sponsored by
About this trial
This is an interventional other trial for P Acnes Colonization
Eligibility Criteria
Inclusion Criteria:
- Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease
Subjects who:
- show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
- have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)
- have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline
Exclusion Criteria:
- Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
- Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
- Subjects who have used other medications which may influence skin surface P acnes levels
- Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study
Sites / Locations
- Skin Study Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Treatment
Arm Description
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily
Outcomes
Primary Outcome Measures
Change From Baseline in Quantitative Bacteriology Measurements at Week 4
Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².
Secondary Outcome Measures
Worst Post Baseline Tolerability Assessment - Erythema
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Dryness
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Scaling
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Worst Post Baseline Tolerability Assessment - Stinging/Burning
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00907101
Brief Title
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Official Title
Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (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 effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
P Acnes Colonization
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Treatment
Arm Type
Experimental
Arm Description
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Other Names:
Epiduo® Gel Apply once daily
Intervention Type
Drug
Intervention Name(s)
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Other Intervention Name(s)
Epiduo® Gel
Intervention Description
Apply once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Quantitative Bacteriology Measurements at Week 4
Description
Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Worst Post Baseline Tolerability Assessment - Erythema
Description
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Time Frame
Week 4
Title
Worst Post Baseline Tolerability Assessment - Dryness
Description
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Time Frame
Week 4
Title
Worst Post Baseline Tolerability Assessment - Scaling
Description
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Time Frame
Week 4
Title
Worst Post Baseline Tolerability Assessment - Stinging/Burning
Description
Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease
Subjects who:
show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)
have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline
Exclusion Criteria:
Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
Subjects who have used other medications which may influence skin surface P acnes levels
Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Skin Study Center
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21607190
Citation
Leyden JJ, Preston N, Osborn C, Gottschalk RW. In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes. J Clin Aesthet Dermatol. 2011 May;4(5):22-6.
Results Reference
derived
Learn more about this trial
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
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