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This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin 1% gel (Akorn Pharmaceuticals) | Experimental |
| |
| Clindamycin 1% gel (Greenstone LLC) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin 1% Gel | Drug | Topical gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | Percent change from baseline to 12 weeks | |
| Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | Percent change in baseline to 12 weeks |
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IInclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 11 | Encino | California | 91436 | United States | ||
| Site 10 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindamycin 1% Gel (Akorn Pharmaceuticals) | Clindamycin 1% Gel: Topical gel |
| FG001 | Clindamycin 1% Gel (Greenstone LLC) | Clindamycin 1% Gel: Topical gel |
| FG002 | Placebo | Placebo: Topical Placebo gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clindamycin 1% Gel (Akorn Pharmaceuticals) | Clindamycin 1% Gel: Topical gel |
| BG001 | Clindamycin 1% Gel (Greenstone LLC) | Clindamycin 1% Gel: Topical gel |
| 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 in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | Posted | Mean | Standard Deviation | % mean change from baseline | Percent change from baseline to 12 weeks |
|
6 months
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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% Gel (Akorn Pharmaceuticals) | Clindamycin 1% Gel: Topical gel | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zaidoon A. Al-Zubaidy | Catawba | 1-980-242-3977 | Zaidoon@catawbaresearch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2018 | Sep 11, 2020 | Prot_SAP_002.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 |
| D005782 | Gels |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | Topical Placebo gel |
|
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Site 1 | Brandon | Florida | 33511 | United States |
| Site 4 | Miramar | Florida | 33027 | United States |
| Site 5 | Miramar | Florida | 33027 | United States |
| Site 2 | Tampa | Florida | 33069 | United States |
| Site 3 | Tampa | Florida | 33618 | United States |
| Site 12 | High Point | North Carolina | 27262 | United States |
| Site 8 | El Paso | Texas | 79902 | United States |
| Site 9 | El Paso | Texas | 79925 | United States |
| Site 6 | Belize City | Belize |
| Site 7 | Belize City | Belize |
| BG002 | Placebo | Placebo: Topical Placebo gel |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | Posted | Mean | Standard Deviation | percent change from baseline | Percent change in baseline to 12 weeks |
|
|
|
| 450 |
| 0 |
| 450 |
| 0 |
| 450 |
| EG001 | Clindamycin 1% Gel (Greenstone LLC) | Clindamycin 1% Gel: Topical gel | 0 | 450 | 0 | 450 | 0 | 450 |
| EG002 | Placebo | Placebo: Topical Placebo gel | 0 | 225 | 0 | 225 | 0 | 225 |
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| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |