Trial Outcomes & Findings for Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes (NCT NCT00907101)
NCT ID: NCT00907101
Last Updated: 2022-08-01
Results Overview
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.
COMPLETED
PHASE4
30 participants
Week 4
2022-08-01
Participant Flow
Participant milestones
| Measure |
Epiduo® Gel
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Baseline characteristics by cohort
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.51 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Skin Type
Dry
|
3 participants
n=99 Participants
|
|
Skin Type
Normal
|
11 participants
n=99 Participants
|
|
Skin Type
Oily
|
5 participants
n=99 Participants
|
|
Skin Type
Combination
|
11 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
I
|
0 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
II
|
3 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
III
|
12 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
IV
|
12 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
V
|
3 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 4Mean 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.
Outcome measures
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Change From Baseline in Quantitative Bacteriology Measurements at Week 4
|
-1.6 log10 CFU/cm2
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Week 4Please 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.
Outcome measures
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Worst Post Baseline Tolerability Assessment - Erythema
None
|
30 participants
|
|
Worst Post Baseline Tolerability Assessment - Erythema
Mild
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4Please 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.
Outcome measures
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Worst Post Baseline Tolerability Assessment - Dryness
None
|
26 participants
|
|
Worst Post Baseline Tolerability Assessment - Dryness
Mild
|
4 participants
|
SECONDARY outcome
Timeframe: Week 4Please 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.
Outcome measures
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Worst Post Baseline Tolerability Assessment - Scaling
None
|
29 participants
|
|
Worst Post Baseline Tolerability Assessment - Scaling
Mild
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4Please 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.
Outcome measures
| Measure |
Epiduo® Gel
n=30 Participants
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
|
|---|---|
|
Worst Post Baseline Tolerability Assessment - Stinging/Burning
None
|
29 participants
|
|
Worst Post Baseline Tolerability Assessment - Stinging/Burning
Mild
|
1 participants
|
Adverse Events
Epiduo® Gel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60