Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes

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: NCT00907101
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition P Acnes Colonization
Intervention Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
36.0  (12.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.3%
White
29
  96.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
1
   3.3%
Not Hispanic or Latino
29
  96.7%
Unknown or Not Reported
0
   0.0%
Skin Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Dry 3
Normal 11
Oily 5
Combination 11
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
I 0
II 3
III 12
IV 12
V 3
VI 0
[1]
Measure Description:

Investigator assessment based on the standard Fitzpatrick Skin Type Scale (I to VI).

TYPE 1: Highly sensitive, always burns, never tans. TYP E 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown.

TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented.

1.Primary Outcome
Title Change From Baseline in Quantitative Bacteriology Measurements at Week 4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: log10 CFU/cm2
-1.6  (0.78)
2.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Erythema
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
None 30
Mild 0
3.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Dryness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
None 26
Mild 4
4.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Scaling
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
None 29
Mild 1
5.Secondary Outcome
Title Worst Post Baseline Tolerability Assessment - Stinging/Burning
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
None 29
Mild 1
Time Frame Safety assessments were conducted for all subjects during each visit (baseline, week 2, week 4/early termination) after enrollment in the study
Adverse Event Reporting Description No AEs were reported during the course of the study.
 
Arm/Group Title Epiduo® Gel
Hide Arm/Group Description Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
All-Cause Mortality
Epiduo® Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Epiduo® Gel
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epiduo® Gel
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth M Nieman
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5000
EMail: elizabeth.nieman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00907101     History of Changes
Other Study ID Numbers: US10127
First Submitted: May 20, 2009
First Posted: May 22, 2009
Results First Submitted: August 12, 2014
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016