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The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental |
| |
| Reference product | Active Comparator |
| |
| Placebo product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin and Benzoyl Peroxide Gel (combination) | Drug |
| ||
| Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions | Baseline to Day 84 | |
| Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions | Baseline to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Clindamycin and Benzoyl Peroxide Gel (combination) |
| FG001 | Reference Product | Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) |
| FG002 | Placebo Product | Placebo gel (combination) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Clindamycin and Benzoyl Peroxide Gel (combination) |
| BG001 | Reference Product | Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions | per protocol population | Posted | Mean | Standard Deviation | percentage of lesion change | Baseline to Day 84 |
|
84 days
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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 | Test Product | Clindamycin and Benzoyl Peroxide Gel (combination) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-9900 | jonathan.schwartz@perrigo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2015 | Oct 22, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2015 | Oct 16, 2020 | SAP_000.pdf |
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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 |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
|
| Placebo gel (combination) | Drug |
|
| BG002 | Placebo Product | Placebo gel (combination) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
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| Primary | Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion change | Baseline to Day 84 |
|
|
|
|
| 385 |
| 0 |
| 385 |
| 0 |
| 385 |
| EG001 | Reference Product | Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) | 0 | 378 | 0 | 378 | 0 | 378 |
| EG002 | Placebo Product | Placebo gel (combination) | 0 | 127 | 0 | 127 | 0 | 127 |
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| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |