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The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Drug | Gel containing Olumacostat Glasaretil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 36 |
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Inclusion Criteria:
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 |
| 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 | Apr 24, 2017 | Nov 19, 2018 |
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| Glendale |
| Arizona |
| 85308 |
| United States |
| Alliance Dermatology & MOHS Center | Phoenix | Arizona | 85032 | United States |
| Dermatology Trial Associates | Bryant | Arkansas | 72022 | United States |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Advanced Skincare Surgery & MedCenter | Fullerton | California | 92835 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Rady Children's Hospital UCSD Pediatric and Adolescent Derm | San Diego | California | 92123 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| University Clinical Trials Inc. | San Diego | California | 92123 | United States |
| Radiant Research, Inc. | Santa Rosa | California | 95405 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| Dermatology Physicians of CT | Shelton | Connecticut | 06484 | 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 |
| Finlay Medical Research | Miami | Florida | 33126 | 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 |
| 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 |
| MOORE Clinical Research, Inc | Tampa | Florida | 33609 | United States |
| Visions Clinical Research | Wellington | Florida | 33414 | United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Marietta Dermatology Clinical Research, Inc. | Marietta | Georgia | 30060 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | 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 |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Lawrence Jeffrey Green MD, LLC | Rockville | Maryland | 20850 | United States |
| Great Lakes Research Group, Inc | Bay City | Michigan | 48706 | United States |
| Henry Ford Medical Center, New Center One | Detroit | Michigan | 48202 | 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 |
| JDR Dermatology Research, LLC | Las Vegas | Nevada | 89148 | United States |
| Acne Treatment & Research Center | Morristown | New Jersey | 07960 | United States |
| Schweiger Dermatology, PLLC | New York | New York | 10022 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| DermResearchCenter of New York, Inc. | Stony Brook | New York | 11790 | United States |
| Sterling Research Group | Cincinnati | Ohio | 45246 | 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 |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | United States |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| Avant Research Associates | Beaumont | Texas | 77702 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Synexus US, LP, dba, Research Across America | Dallas | Texas | 75234 | United States |
| Suzanne Bruce and Associates, P.A. The Center for Skin Research | Houston | Texas | 77056 | United States |
| Austin Institute for Clinical Research, Inc | Pflugerville | Texas | 78660 | United States |
| Synexus US, LP, dba, Research Across America | Plano | Texas | 75093 | 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 |
| Houston Center for Clinical Research | Sugar Land | Texas | 77479 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| Premier Specialists | Kogarah | New South Wales | 2217 | Australia |
| St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 4102 | Australia |
| North Eastern Health Specialists | Hectorville | South Australia | 5073 | Australia |
| Skin & Cancer Foundation Inc. | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Burswood Dermatology | Victoria Park | Western Australia | 6100 | Australia |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research | Mississauga | Ontario | L5H 1G9 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N2 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Windsor Research Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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 |
|---|---|---|
| BG000 | Olumacostat Glasaretil Gel, 5.0% | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face |
| 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 |
|
| 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 | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Safety Population | Posted | Number | Participants | Day 1 - Week 36 |
|
|
|
Baseline to Week 36
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 | 0 | 741 | 8 | 741 | 281 | 741 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
| 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 |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Headache | Nervous system disorders | 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 | Apr 10, 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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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
| Title | Measurements |
|---|---|
|
| Adverse Events (Not Reported) |
|
| Burning/Stinging (None) |
|
| Burning/Stinging (Mild) |
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| Burning/Stinging (Moderate) |
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| Burning/Stinging (Severe) |
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| Burning/Stinging (Not Reported) |
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| Pruritus (None) |
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| Pruritus (Mild) |
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| Pruritus (Moderate) |
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| Pruritus (Severe) |
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| Pruritus (Not Reported) |
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| Erythema (None) |
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| Erythema (Mild) |
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| Erythema (Moderate) |
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| Erythema (Severe) |
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| Erythema (Not Reported) |
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| Dryness (None) |
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| Dryness (Mild) |
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| Dryness (Moderate) |
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| Dryness (Severe) |
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| Dryness (Not Reported) |
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| Peeling (None) |
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| Peeling (Mild) |
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| Peeling (Moderate) |
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| Peeling (Severe) |
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| Peeling (Not Reported) |
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