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The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Experimental | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks |
|
| Olumacostat Glasaretil Gel, Vehicle | Placebo Comparator | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Drug | Gel containing Olumacostat Glasaretil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 | Baseline and Week 12 |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 | Baseline and Week 12 |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions
| Baseline and Week 12 |
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Inclusion Criteria:
Signed informed consent and, for subjects under legal adult age, signed assent
Age ≥ 9 years
Clinical diagnosis of facial acne vulgaris defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Zib | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avant Research Associates, LLC | Guntersville | Alabama | 35976 | United States | ||
| Advanced Research Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Olumacostat Glasaretil Gel, 5.0% | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks |
| FG001 | Olumacostat Glasaretil Gel, Vehicle | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| 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 | Yes | No | No | Study Protocol | Oct 6, 2016 | Nov 19, 2018 |
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| Olumacostat Glasaretil Gel, Vehicle | Other | Vehicle (placebo) gel |
|
| Glendale |
| Arizona |
| 85308 |
| United States |
| Dermatology Trial Associates | Bryant | Arkansas | 72022 | United States |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Advanced Skincare Surgery & MedCenter | Fullerton | California | 92835 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| Radiant Research, Inc. | Santa Rosa | California | 95405 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | United States |
| Center for Clincial and Cosmetic Research | Aventura | Florida | 33180 | United States |
| Florida Academic Centers Research & Education | Coral Gables | Florida | 33134 | United States |
| Aby's New GEneration Research Inc. | Hialeah | Florida | 33015 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| Floridian Research Institute | Miami | Florida | 33145 | United States |
| Pioneer Clinical Research | Pembroke Pines | Florida | 33028 | United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| MOORE Clinical Research, Inc | Tampa | Florida | 33609 | United States |
| Visions Clinical Research | Wellington | Florida | 44414 | United States |
| Marietta Dermatology Clinical Research, Inc. | Marietta | Georgia | 30060 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Henry Ford Medical Center, New Center One | Detroit | Michigan | 48202 | United States |
| JDR Dermatology Research, LLC | Las Vegas | Nevada | 89148 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Sterling Research Group | Cincinnati | Ohio | 45246 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37992 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Avant Research Associates | Beaumont | Texas | 77702 | United States |
| Synexus US, LP, dba, Research Across America | Dallas | Texas | 75234 | United States |
| Suzanne Bruce and Associates, P.A. The Center for Skin | Houston | Texas | 77056 | United States |
| Austin Institute for Clinical Research, Inc | Pflugerville | Texas | 78660 | United States |
| Houston Center for Clinical Research | Sugar Land | Texas | 77479 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| The Skin Centre | Benowa | 4217 | Australia |
| Premier Specialists | Kogarah | 2217 | Australia |
| Sinclair Dermatology | Melbourne | 3002 | Australia |
| Burswood Dermatology | Victoria Park | 6100 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| Enverus Medical Research | Surrey | British Columbia | V3V 006 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| DermEdge Research | Mississauga | Ontario | L5H 1G9 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olumacostat Glasaretil Gel, 5.0% | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks |
| BG001 | Olumacostat Glasaretil Gel, Vehicle | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is a scale to numerically classify skin color, defined by the response to ultraviolet (UV) light with the following categories: Type I Burns easily, rarely tans Type II Burns easily, tans minimally Type III Burns moderately, tans gradually Type IV Burns minimally, tans well Type V Rarely burns, tans profusely Type VI Never burns, deeply pigmented | Count of Participants | 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 | Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 | Intent-to-Treat | Posted | Least Squares Mean | Standard Deviation | Lesions | Baseline and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 | Intent-to-Treat | Posted | Least Squares Mean | Standard Deviation | Lesions | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions
| Intent-to-Treat | Posted | Count of Participants | Participants | Baseline and Week 12 |
|
Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
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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 | Olumacostat Glasaretil Gel, 5.0% | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks | 0 | 491 | 1 | 491 | 108 | 491 |
| EG001 | Olumacostat Glasaretil Gel, Vehicle | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | 0 | 248 | 0 | 248 | 28 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | Systematic Assessment |
| ||
| Application site erythema | General disorders | Systematic Assessment |
| ||
| Application site pain | General disorders | Systematic Assessment |
| ||
| Application site pruritus | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2017 | Nov 19, 2018 | SAP_001.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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| >=65 years |
|
| 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Australia |
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| Type II |
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| Type III |
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| Type IV |
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| Type V |
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| Type VI |
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| Units | Counts |
|---|---|
| Participants |
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