P Acnes Colonization
Conditions
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.
Interventions
DRUGAdapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Apply once daily
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quantitative Bacteriology Measurements at Week 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| Worst Post Baseline Tolerability Assessment - Erythema | Week 4 | 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 | Week 4 | 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 | Week 4 | 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 | Week 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epiduo® Gel Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Epiduo® Gel |
|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 12.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type I | 0 participants |
| Fitzpatrick Skin Type II | 3 participants |
| Fitzpatrick Skin Type III | 12 participants |
| Fitzpatrick Skin Type IV | 12 participants |
| Fitzpatrick Skin Type V | 3 participants |
| Fitzpatrick Skin Type VI | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
| Skin Type Combination | 11 participants |
| Skin Type Dry | 3 participants |
| Skin Type Normal | 11 participants |
| Skin Type Oily | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epiduo® Gel | Change From Baseline in Quantitative Bacteriology Measurements at Week 4 | -1.6 log10 CFU/cm2 | Standard Deviation 0.78 |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Dryness | None | 26 participants |
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Dryness | Mild | 4 participants |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Erythema | None | 30 participants |
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Erythema | Mild | 0 participants |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Scaling | None | 29 participants |
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Scaling | Mild | 1 participants |
Secondary
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.
Time frame: Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Stinging/Burning | None | 29 participants |
| Epiduo® Gel | Worst Post Baseline Tolerability Assessment - Stinging/Burning | Mild | 1 participants |