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NCT03127956 Clinical Trial

A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03127956
Other study ID # DRM01B-ACN05
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 21, 2017
Est. completion date April 27, 2018

Study information
Verified date July 2021
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris

Recruitment information / eligibility
Status Completed
Enrollment 748
Est. completion date April 27, 2018
Est. primary completion date April 27, 2018
Accepts healthy volunteers No
Gender All
Age group 9 Years and older
Eligibility Inclusion Criteria: - Signed informed consent or assent (for subjects under legal adult age) - Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies. - Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol - Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics. Exclusion Criteria: - Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator - Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil

Locations
Country Name City State
Australia The Skin Centre Benowa Queensland
Australia Skin & Cancer Foundation Inc. Carlton Victoria
Australia Sinclair Dermatology East Melbourne Victoria
Australia Fremantle Dermatology Fremantle Western Australia
Australia North Eastern Health Specialists Hectorville South Australia
Australia Premier Specialists Kogarah New South Wales
Australia St George Dermatology and Skin Cancer Centre Kogarah New South Wales
Australia Woden Dermatology Phillip Australian Capital Territory
Australia Burswood Dermatology Victoria Park Western Australia
Australia Veracity Clinical Research Woolloongabba Queensland
Canada SimcoDerm Medical and Surgical Dermatology Center Barrie Ontario
Canada Institute for Skin Advancement Calgary Alberta
Canada Lynderm Research Inc. Markham Ontario
Canada DermEdge Research Mississauga Ontario
Canada North Bay Dermatology Centre North Bay Ontario
Canada The Centre for Dermatology Richmond Hill Ontario
Canada Enverus Medical Research Surrey British Columbia
Canada Research Toronto Toronto Ontario
Canada Windsor Research Inc. Windsor Ontario
Canada XLR8 Medical Research Windsor Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
United States Anaheim Clinical Trials Anaheim California
United States DermResearch, Inc Austin Texas
United States Center for Clincial and Cosmetic Research Aventura Florida
United States Great Lakes Research Group, Inc Bay City Michigan
United States Avant Research Associates Beaumont Texas
United States Alpine Clinical Research Center Boulder Colorado
United States Dermatology Trial Associates Bryant Arkansas
United States Forefront Dermatology Carmel Indiana
United States Sterling Research Group Cincinnati Ohio
United States J&S Studies, Inc. College Station Texas
United States Florida Academic Centers Research & Education Coral Gables Florida
United States Meridian Clincial Research Dakota Dunes South Dakota
United States Synexus US, LP, dba, Research Across America Dallas Texas
United States Horizons Clinical Research Center, LLC Denver Colorado
United States Henry Ford Medical Center, New Center One Detroit Michigan
United States Center for Dermatology Clinical Research, Inc. Fremont California
United States Minnesota Clinical Study Center Fridley Minnesota
United States Advanced Skincare Surgery & MedCenter Fullerton California
United States Advanced Research Associates Glendale Arizona
United States Cyn3rgy Research Gresham Oregon
United States Avant Research Associates, LLC Guntersville Alabama
United States Aby's New Generation Research Inc. Hialeah Florida
United States Suzanne Bruce and Associates, P.A. The Center for Skin Research Houston Texas
United States Clinical Partners, LLC Johnston Rhode Island
United States Health Awareness, Inc. Jupiter Florida
United States The Skin Wellness Center Knoxville Tennessee
United States JDR Dermatology Research, LLC Las Vegas Nevada
United States Dermatology Research Associates Los Angeles California
United States Skin Sciences, PLLC Louisville Kentucky
United States The Education & Research Foundation, Inc. Lynchburg Virginia
United States Marietta Dermatology Clinical Research, Inc. Marietta Georgia
United States Clinical Trials Management, LLC Metairie Louisiana
United States Finlay Medical Research Miami Florida
United States Floridian Research Institute Miami Florida
United States Acne Treatment & Research Center Morristown New Jersey
United States International Clinical Research - Tennessee LLC Murfreesboro Tennessee
United States Clinical Research Associates, Inc. Nashville Tennessee
United States Tennessee Clinical Research Center Nashville Tennessee
United States DelRicht Research New Orleans Louisiana
United States Schweiger Dermatology, PLLC New York New York
United States Meridian Clinical Research, LLC Norfolk Nebraska
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States Meridian Clinical Research Omaha Nebraska
United States Quality Clinical Research Inc. Omaha Nebraska
United States Kansas City Dermatology, PA Overland Park Kansas
United States Pioneer Clinical Research Pembroke Pines Florida
United States Austin Institute for Clinical Research, Inc Pflugerville Texas
United States Alliance Dermatology & MOHS Center Phoenix Arizona
United States Radiant Research, Inc. Pinellas Park Florida
United States Synexus US, LP, dba, Research Across America Plano Texas
United States Health Awareness, Inc Port Saint Lucie Florida
United States Skin Search of Rochester, Inc. Rochester New York
United States Lawrence Jeffrey Green MD, LLC Rockville Maryland
United States Northwest Arkansas Clinical Trials Center Rogers Arkansas
United States Arlington Dermatology Rolling Meadows Illinois
United States Northern California Research Sacramento California
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Progressive Clinical Research, PA San Antonio Texas
United States Rady Children's Hospital UCSD Pediatric and Adolescent Derm San Diego California
United States TCR Medical Corporation San Diego California
United States University Clinical Trials Inc. San Diego California
United States International Clinical Research-US, LLC Sanford Florida
United States Radiant Research, Inc. Santa Rosa California
United States Dermatology Physicians of CT Shelton Connecticut
United States Premier Clinical Research Spokane Washington
United States DermResearchCenter of New York, Inc. Stony Brook New York
United States Houston Center for Clinical Research Sugar Land Texas
United States Lenus Research & Medical Group Sweetwater Florida
United States MOORE Clinical Research, Inc Tampa Florida
United States Mercy Research Washington Missouri
United States Visions Clinical Research Wellington Florida
United States Research Institute of the Southeast, LLC West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Dermira, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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