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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epiduo gel | Experimental |
|
|
| BPO gel | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiduo gel | Drug | Once daily application on the face in the evening for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrzej LANGNER, Professor | Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologiczna Klinika Uzdrowiskowa | Iwonicz-Zdrój | 38-440 | Poland |
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| Label | URL |
|---|---|
| Related Info | View source |
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40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Epiduo Gel | |
| FG001 | Benzoyl Peroxide (BPO) Gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epiduo Gel | |
| BG001 | Benzoyl Peroxide (BPO) Gel | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent To Treat (ITT)/Last Observation Carried Forward (LOCF) | Posted | Jul 2011 | Mean | Standard Deviation | Log10 cfu/cm² | Week 12 |
|
During the study (from baseline to Week 12)
Questioning at each follow up visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epiduo Gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzaneh SIDOU | Galderma | 00 33 4 93 95 70 51 | farzaneh.sidou@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| BPO | Drug | Once daily application on the face in the evening for 12 weeks |
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | ITT (LOCF) | Posted | Median | Full Range | Percent change (%) | Week 12 |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Benzoyl Peroxide (BPO) Gel | 0 | 20 | 0 | 20 |
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| D009930 |
| Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000068816 | Adapalene |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |