Acne Vulgaris
Conditions
Keywords
P. acnes, Acne vulgaris
Brief summary
The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
Interventions
DRUGEpiduo gel
Once daily application on the face in the evening for 12 weeks
DRUGBPO
Once daily application on the face in the evening for 12 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with facial acne, * Subjects with high levels of P. acnes counts on the forehead
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning a pregnancy during the study, * Subjects with acne conglobata, acne fulminans, secondary acne * Subjects with known or suspected allergy to one of the test product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes | Week 12 | Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change (%) in Inflammatory Lesion Counts | Week 12 | Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated. |
Countries
Poland
Participant flow
Recruitment details
40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010
Participants by arm
| Arm | Count |
|---|---|
| Epiduo Gel | 20 |
| Benzoyl Peroxide (BPO) Gel | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Benzoyl Peroxide (BPO) Gel | Epiduo Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Continuous | 21.4 years STANDARD_DEVIATION 2.9 | 22.9 years STANDARD_DEVIATION 4.5 | 22.1 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment Poland | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.
Time frame: Week 12
Population: Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epiduo Gel | Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes | -1.94 Log10 cfu/cm² | Standard Deviation 1.69 |
| Benzoyl Peroxide (BPO) Gel | Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes | -1.56 Log10 cfu/cm² | Standard Deviation 1.25 |
Secondary
Percent Change (%) in Inflammatory Lesion Counts
Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.
Time frame: Week 12
Population: ITT (LOCF)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Epiduo Gel | Percent Change (%) in Inflammatory Lesion Counts | -62.8 Percent change (%) |
| Benzoyl Peroxide (BPO) Gel | Percent Change (%) in Inflammatory Lesion Counts | -68.1 Percent change (%) |