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The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | Active Comparator |
| |
| Reference Product | Active Comparator |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) | Drug | Applied to the entire face twice daily for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesions | 10 weeks | |
| Percent Change From Baseline in Non-inflammatory Lesions | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindamycin 1%/Benzoyl Peroxide 5% | Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks |
| FG001 | Reference Product | Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks |
| FG002 | Vehicle | Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clindamycin 1%/Benzoyl Peroxide 5% | Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks |
| BG001 | Reference Product | Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks |
| 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 | Percent Change From Baseline in Inflammatory Lesions | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion reduction | 10 weeks |
|
10 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 | Clindamycin 1%/Benzoyl Peroxide 5% | Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site dryness | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-9900 | jonathan.schwartz@perrigo.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 |
|---|---|
| D002981 | Clindamycin |
| D001585 | Benzoyl Peroxide |
| C466951 | clindamycin phosphate benzoyl peroxide combination |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) | Drug | Applied to the entire face twice daily for 10 weeks |
|
| Placebo | Drug | Placebo |
|
| BG002 | Vehicle | Placebo: Placebo |
| 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 |
|
Placebo: Placebo
|
|
|
| Primary | Percent Change From Baseline in Non-inflammatory Lesions | Per protocol population | Posted | Mean | Standard Deviation | percentage of lesion reduction | 10 weeks |
|
|
|
|
| Secondary | Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. | per-protocol population | Posted | Number | participants | 10 weeks |
|
|
|
|
| 0 |
| 522 |
| 49 |
| 522 |
| EG001 | Reference Product | Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks | 0 | 516 | 49 | 516 |
| EG002 | Vehicle | Placebo: Placebo | 0 | 517 | 72 | 517 |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |