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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 |
|---|---|---|---|---|---|---|
| Alliance Dermatology & MOHS Center | Phoenix | Arizona | 85032 | United States | ||
| Anaheim Clinical Trials |
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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 |
|
| Anaheim |
| California |
| 92801 |
| United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Rady Children's Hospital UCSD Pediatric and Adolescent Derm | San Diego | California | 92123 | United States |
| University Clinical Trials Inc. | San Diego | California | 92123 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| Dermatology Physicians of CT | Shelton | Connecticut | 06484 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Health Awareness, Inc | Port Saint Lucie | Florida | 34952 | United States |
| International Clinical Research-US, LLC | Sanford | Florida | 32771 | United States |
| Lenus Research & Medical Group | Sweetwater | Florida | 33172 | United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Arlington Dermatology | Arlington Heights | Illinois | 60005 | United States |
| Forefront Dermatology | Carmel | Indiana | 46032 | United States |
| Kansas City Dermatology, PA | Overland Park | Kansas | 66215 | United States |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | United States |
| Lawrence Jeffrey Green MD, LLC | Rockville | Maryland | 20850 | United States |
| Great Lakes Research Group, Inc | Bay City | Michigan | 48706 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Mercy Research | Washington | Missouri | 63090 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| Quality Clinical Research Inc | Omaha | Nebraska | 68114 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Acne Treatment & Research Center | Morristown | New Jersey | 07960 | United States |
| Schweiger Dermatology, PLLC | New York | New York | 10022 | United States |
| DermResearchCenter of New York, Inc. | Stony Brook | New York | 11790 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Meridian Clincial Research | Dakota Dunes | South Dakota | 57049 | United States |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | United States |
| International Clinical Research-Tennesse LLC | Murfreesboro | Tennessee | 37130 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| J &S Studies, Inc | College Station | Texas | 77845 | United States |
| Synexus US, LP, dba, Research Across America | Murphy | Texas | 75094 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78213 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| North Eastern Health Specialists | Hectorville | South Australia | 5073 | Australia |
| Skin & Cancer Foundation Inc. | Carlton | Victoria | 3053 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N2 | Canada |
| Windsor Research Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| COMPLETED |
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| 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 | Count of Participants | 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 | 485 | 1 | 485 | 89 | 485 |
| EG001 | Olumacostat Glasaretil Gel, Vehicle | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | 0 | 258 | 3 | 258 | 33 | 258 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Bipolar disorder | 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 | Jan 19, 2018 | 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 |
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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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| 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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