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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%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Experimental | apply a thin layer of gel to the face |
|
| BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | Active Comparator | apply a thin layer of the gel to the face |
|
| Placebo topical gel | Placebo Comparator | apply a thin layer of the gel to the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Drug |
| ||
| BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. | Baseline and 10 Weeks |
| Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. | Baseline and 10 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh V Deshpande | Glenmark Pharmaceuticals Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenmark Investigational Site 13 | Anaheim | California | United States | |||
| Glenmark Investigational Site 6 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Test: A thin layer of gel was applied to the entire affected areas on the face twice a day. |
| FG001 | BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Placebo | Drug |
|
| Long Beach |
| California |
| United States |
| Glenmark Investigational Site 15 | Los Angeles | California | United States |
| Glenmark Investigational Site12 | West Covina | California | United States |
| Glenmark Investigational Site 4 | Brandon | Florida | United States |
| Glenmark Investigational Site 1 | Miami | Florida | United States |
| Glenmark Investigational Site 8 | Miami | Florida | United States |
| Glenmark Investigational Site 9 | Miramar | Florida | United States |
| Glenmark Investigational Site 2 | St. Petersburg | Florida | United States |
| Glenmark Investigational Site 5 | Louisville | Kentucky | United States |
| Glenmark Investigational Site7 | Upper Saint Clair | Pennsylvania | United States |
| Glenmark Investigational Site 14 | Greenville | South Carolina | United States |
| Glenmark Investigational Site 3 | Nashville | Tennessee | United States |
| Glenmark Investigational Site 10 | Belize City | Belize |
| Glenmark Investigational Site 11 | Belize City | Belize |
Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.
| FG002 | Placebo Topical Gel | Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day. |
| COMPLETED |
|
| NOT COMPLETED |
|
A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the overall number of subjects in the Baseline Participants module is not consistent with any of the rows of the Participant Flow module.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel |
| BG001 | Reference | Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% |
| BG002 | Placebo | Placebo: Placebo topical gel |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
|
| 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 in the Number of Inflamed Lesions (Papules/Pustules) | The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline and 10 Weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline and 10 Weeks |
|
|
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A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the total number of Participants at risk is not consistent with any of the rows of the Participant Flow module.
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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 | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | 0 | 432 | 0 | 432 | ||
| EG001 | Reference | BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | 0 | 430 | 0 | 430 | ||
| EG002 | Placebo | Placebo topical gel | 0 | 211 | 0 | 211 |
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Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy Tyrrell | Glenmark Pharmaceuticals Ltd | 91 2267720000 | clinicaltrialsdisclosuredesk@glenmarkpharma.com |
| 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 |
| D005782 | Gels |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
|
|