A Phase 4 interventional study of Epiduo gel and BPO in Acne Vulgaris, sponsored by Galderma R&D. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 40 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.
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Exclusion Criteria:
* Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks
Drug: Epiduo gel
* Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks
Drug: BPO
Once daily application on the face in the evening for 12 weeks
Also known as: Epiduo
Once daily application on the face in the evening for 12 weeks
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
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
40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010
| Milestone | Epiduo Gel | Benzoyl Peroxide (BPO) Gel |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 19 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| Log10 cfu/cm² | Epiduo Gel | Benzoyl Peroxide (BPO) Gel |
|---|---|---|
| Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes | -1.94 ± 1.69 | -1.56 ± 1.25 |
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.
| Percent change (%) | Epiduo® Gel | BPO Gel |
|---|---|---|
| Percent Change (%) in Inflammatory Lesion Counts | -62.8 (-93.3 to 11.1) | -68.1 (-100 to 11.1) |
Collected over During the study (from baseline to Week 12). Non-serious events are listed at a 2.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epiduo Gel | — | 0/20 (0%) | 1/20 (5%) |
| Benzoyl Peroxide (BPO) Gel | — | 0/20 (0%) | 0/20 (0%) |
| Event | Epiduo Gel | Benzoyl Peroxide (BPO) Gel |
|---|---|---|
| SinusitisInfections and infestations | 1/20 | 0/20 |
| Age, Categorical(Participants) | Epiduo Gel | Benzoyl Peroxide (BPO) Gel | Total |
|---|---|---|---|
| <=18 years | 3 | 4 | 7 |
| Between 18 and 65 years | 17 | 16 | 33 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Epiduo Gel | Benzoyl Peroxide (BPO) Gel | Total |
|---|---|---|---|
| Mean | 22.9 ± 4.5 | 21.4 ± 2.9 | 22.1 ± 3.8 |
| Sex: Female, Male(Participants) | Epiduo Gel | Benzoyl Peroxide (BPO) Gel | Total |
|---|---|---|---|
| Female | 18 | 16 | 34 |
| Male | 2 | 4 | 6 |
| Region of Enrollment(participants) | Epiduo Gel | Benzoyl Peroxide (BPO) Gel | Total |
|---|---|---|---|
| Poland | 20 | 20 | 40 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Galderma R&D