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To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perrigo active | Experimental | Test product |
|
| Reference active | Active Comparator | RLD product |
|
| Perrigo placebo | Placebo Comparator | placebo product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene and Benzoyl Peroxide Topical Gel | Drug | Test product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | Day 1 to week 12 | |
| Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | Per protocol population | Day 1 to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consultants | High Point | North Carolina | 27262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Adapalene and Benzoyl Peroxide Topical Gel |
| FG001 | Reference Product | Epiduo Topical Gel |
| FG002 | Placebo Product | Placebo gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perrigo Active | Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product |
| BG001 | Reference Active | RLD product Epiduo Topical Product: RLD product |
| 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 | Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion change | Day 1 to week 12 |
|
12 Weeks
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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 | Perrigo Active | Test product Adapalene and Benzoyl Peroxide Topical Gel: Test product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical Radiculopathy | Nervous system disorders | Non-systematic Assessment |
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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 | Sep 28, 2017 | Nov 10, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2017 | Nov 10, 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 |
|---|---|
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Epiduo Topical Product |
| Drug |
RLD product |
|
| Placebo | Drug | Placebo gel |
|
| BG002 | Perrigo Placebo | placebo product Placebo: Placebo gel |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | Per protocol population | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion change | Day 1 to week 12 |
|
|
|
|
| 0 |
| 329 |
| 0 |
| 329 |
| 0 |
| 329 |
| EG001 | Reference Active | RLD product Epiduo Topical Product: RLD product | 0 | 331 | 0 | 331 | 0 | 331 |
| EG002 | Perrigo Placebo | placebo product Placebo: Placebo gel | 0 | 165 | 2 | 165 | 0 | 165 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |