A Phase 4 interventional study of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) in P Acnes Colonization, sponsored by Galderma R&D. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by Galderma R&D · Phase 4, Interventional, and Other
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who:
Exclusion Criteria:
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily
Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Apply once daily
Also known as: Epiduo® Gel
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
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
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
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
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
| Milestone | Epiduo® Gel |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| log10 CFU/cm2 | Epiduo® Gel |
|---|---|
| Change From Baseline in Quantitative Bacteriology Measurements at Week 4 | -1.6 ± 0.78 |
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.
| participants | Epiduo® Gel |
|---|---|
| None | 30 |
| Mild | 0 |
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.
| participants | Epiduo® Gel |
|---|---|
| None | 26 |
| Mild | 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.
| participants | Epiduo® Gel |
|---|---|
| None | 29 |
| Mild | 1 |
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.
| participants | Epiduo® Gel |
|---|---|
| None | 29 |
| Mild | 1 |
Collected over Safety assessments were conducted for all subjects during each visit (baseline, week 2, week 4/early termination) after enrollment in the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epiduo® Gel | — | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Epiduo® Gel |
|---|---|
| Mean | 36.0 ± 12.51 |
| Sex: Female, Male(Participants) | Epiduo® Gel |
|---|---|
| Female | 8 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Epiduo® Gel |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Epiduo® Gel |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 0 |
| Skin Type(participants) | Epiduo® Gel |
|---|---|
| Dry | 3 |
| Normal | 11 |
| Oily | 5 |
| Combination | 11 |
| Fitzpatrick Skin Type(participants) | Epiduo® Gel |
|---|---|
| I | 0 |
| II | 3 |
| III | 12 |
| IV | 12 |
| V | 3 |
| VI | 0 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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