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A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active Comparator | Test product |
|
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active Comparator | Reference product |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Drug | Topical Gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Inflammatory Lesions | The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules). | Baseline and week 11 |
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Inclusion Criteria:
Exclusion Criteria:
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FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Test product 1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel |
| FG001 | DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Reference product 1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel |
| FG002 | Placebo | Placebo : Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Test product 1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel |
| BG001 | DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel |
| 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 | Reduction of Inflammatory Lesions | The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules). | per-protocol population | Posted | Number | percentage reduction of lesions | Baseline and week 11 |
|
11 week treatment period
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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 | 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Test product 1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| application site dryness | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager | Perrigo Company | 718-960-0119 | 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 |
|---|---|
| C466951 | clindamycin phosphate benzoyl peroxide combination |
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|
| Placebo | Drug | Placebo |
|
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
| BG002 | Placebo | Placebo : Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Placebo |
Placebo : Placebo |
|
|
|
| 1 |
| 40 |
| 200 |
| EG001 | DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Reference product 1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel | 0 | 35 | 202 |
| EG002 | Placebo | Placebo : Placebo | 1 | 28 | 200 |
| Hematuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mild Bipolar Conduct Disorder | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Application Site Burning | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
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