Clinical trial NCT03127956: A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Official title: An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 748
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
timeFrame: Day 1 - Week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: Avant Research Associates, LLC
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Fullerton
country: United States
facility: Advanced Skincare Surgery & MedCenter
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital UCSD Pediatric and Adolescent Derm
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: San Diego
country: United States
facility: University Clinical Trials Inc.
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Shelton
country: United States
facility: Dermatology Physicians of CT
state: Connecticut
city: Aventura
country: United States
facility: Center for Clincial and Cosmetic Research
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research & Education
state: Florida
city: Hialeah
country: United States
facility: Aby's New Generation Research Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Pembroke Pines
country: United States
facility: Pioneer Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc
state: Florida
city: Sanford
country: United States
facility: International Clinical Research-US, LLC
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Carmel
country: United States
facility: Forefront Dermatology
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Rockville
country: United States
facility: Lawrence Jeffrey Green MD, LLC
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Washington
country: United States
facility: Mercy Research
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research, LLC
state: Nevada
city: Morristown
country: United States
facility: Acne Treatment & Research Center
state: New Jersey
city: New York
country: United States
facility: Schweiger Dermatology, PLLC
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Meridian Clincial Research
state: South Dakota
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: Beaumont
country: United States
facility: Avant Research Associates
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Synexus US, LP, dba, Research Across America
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A. The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc
state: Texas
city: Plano
country: United States
facility: Synexus US, LP, dba, Research Across America
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Hectorville
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Carlton
country: Australia
facility: Skin & Cancer Foundation Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Research Inc.
state: Ontario
Study officials:
affiliation: Dermira, Inc.
name: Beth Zib
role: STUDY_DIRECTOR
References: