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The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | GDC 268 Lotion applied topically as directed. |
|
| Reference Product | Active Comparator | Clindamycin Phosphate Lotion, 1% applied topically as directed. |
|
| Placebo | Placebo Comparator | GDC Vehicle lotion applied topically as directed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC 268 Lotion | Drug | GDC 268 is a topical lotion |
| |
| Clindamycin Phosphate Lotion 1% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in the Number of Inflamed Lesions | Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules). | 12 weeks |
| Mean Percent Change in the Non-inflammatory Lesion Counts | Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 | Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage. | Day 1 through Day 85 |
Inclusion Criteria:
Exclusion Criteria:
Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 07 | Fort Smith | Arkansas | 72916 | United States | ||
| Site 22 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion |
| FG001 | Reference Product | Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 6, 2019 |
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| Drug |
Clindamycin Phosphate Lotion is an FDA-approved drug product |
|
| GDC Vehicle Lotion | Drug | GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs |
|
| 12 weeks |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Site 25 | Fountain Valley | California | 92708 | United States |
| Site 33 | Northridge | California | 91324 | United States |
| Site 30 | San Diego | California | 92103 | United States |
| Site 44 | Aventura | Florida | 33180 | United States |
| Site 36 | Brandon | Florida | 33511 | United States |
| Site 45 | DeLand | Florida | 32720 | United States |
| Site 41 | Largo | Florida | 33770 | United States |
| Site 38 | Miami | Florida | 33145 | United States |
| Site 35 | Miami Lakes | Florida | 33014 | United States |
| Site 37 | North Miami Beach | Florida | 33162 | United States |
| Site 26 | St. Petersburg | Florida | 33709 | United States |
| Site 42 | Tampa | Florida | 33609 | United States |
| Site 01 | West Palm Beach | Florida | 33406 | United States |
| Site 10 | Newnan | Georgia | 30263 | United States |
| Site 09 | Boise | Idaho | 83704 | United States |
| Site 05 | Rolling Meadows | Illinois | 60008 | United States |
| Site 02 | Plainfield | Indiana | 46168 | United States |
| Site 27 | Overland Park | Kansas | 66215 | United States |
| Site 28 | Clarkston | Michigan | 48346 | United States |
| Site 24 | Fridley | Minnesota | 55432 | United States |
| Site 49 | Omaha | Nebraska | 68134 | United States |
| Site 06 | High Point | North Carolina | 27262 | United States |
| Site 32 | Raleigh | North Carolina | 27612 | United States |
| Site 19 | Dublin | Ohio | 43016 | United States |
| Site 17 | Gresham | Oregon | 97030 | United States |
| Site 34 | Philadelphia | Pennsylvania | 19103 | United States |
| Site 20 | Warwick | Rhode Island | 02886 | United States |
| Site 08 | Anderson | South Carolina | 29621 | United States |
| Site 29 | Chattanooga | Tennessee | 37421 | United States |
| Site 03 | Murfreesboro | Tennessee | 37130 | United States |
| Site 04 | Nashville | Tennessee | 37215 | United States |
| Site 43 | Sugar Land | Texas | 77479 | United States |
| FG002 | Placebo | GDC Vehicle lotion applied topically as directed. GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs |
| COMPLETED |
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| NOT COMPLETED |
|
The baseline population includes the Safety and mITT populations, defined as all randomized subjects who applied at least one dose of the test article.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion |
| BG001 | Reference Product | Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product |
| BG002 | Placebo | GDC Vehicle lotion applied topically as directed. GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs |
| 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, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Other category includes subjects that identified with more than one race. | Count of Participants | Participants |
| |||||||||||||||
| Investigator's Global Assessment | To be eligible for study participation, subjects required a clinical diagnosis of mild to severe facial acne vulgaris defined as Grade 2, 3, or 4 on the IGA at Baseline. The IGA (Investigator's Global Assessment) Scale is measured using a five-point scale from 0=Clear to 4=Severe. | Count of Participants | Participants |
| |||||||||||||||
| Non-Inflammatory Lesions | Mean | Standard Deviation | Lesions |
| |||||||||||||||
| Inflammatory Lesions | Mean | Standard Deviation | Lesions |
|
| 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 | Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules). | Analysis population is the per-protocol population defined as all subjects in the modified Intent-to-treat (mITT) population who met the following criteria: 1) Met all I/E criteria; 2) No evidence of material dosing noncompliance, 3) Completed the primary endpoint evaluation at Week 12 within the designated visit window (Day 85 ± 6 days), 4) Had no protocol violations that would affect the treatment evaluation, and 5) Did not use any prohibited medications. | Posted | Mean | Standard Deviation | percent change | 12 weeks |
|
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| Primary | Mean Percent Change in the Non-inflammatory Lesion Counts | Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts. | Data based on the per-protocol population. | Posted | Mean | Standard Deviation | percent change | 12 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 | Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment. | Based on the per-protocol population. | Posted | Count of Participants | Participants | 12 weeks |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Adverse Events | Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage. | Based on the Safety population defined as all subjects randomized and applied at least one dose. | Posted | Count of Participants | Participants | Day 1 through Day 85 |
|
|
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 | Test Product | GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion | 0 | 496 | 0 | 496 | 0 | 496 |
| EG001 | Reference Product | Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug | 0 | 491 | 0 | 491 | 0 | 491 |
| EG002 | Placebo | GDC Vehicle lotion applied topically as directed. GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs | 0 | 249 | 0 | 249 | 0 | 249 |
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The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gage Development Clinical Trials | Gage Development Company | 1-847-999-0600 | clinicalinfo@capstonedevservices.com |
| Apr 2, 2021 |
| Prot_SAP_000.pdf |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other (multiple) |
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| 3-Moderate |
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| 4-Severe |
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| Units | Counts |
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| Participants |
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| Participants |
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