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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olumacostat Glasaretil Gel, 5.0%
Sponsored by
Dermira, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avant Research Associates, LLC
  • Advanced Research Associates
  • Alliance Dermatology & MOHS Center
  • Dermatology Trial Associates
  • Northwest Arkansas Clinical Trials Center
  • Anaheim Clinical Trials
  • Center for Dermatology Clinical Research, Inc.
  • Advanced Skincare Surgery & MedCenter
  • Dermatology Research Associates
  • Northern California Research
  • Rady Children's Hospital UCSD Pediatric and Adolescent Derm
  • TCR Medical Corporation
  • University Clinical Trials Inc.
  • Radiant Research, Inc.
  • Alpine Clinical Research Center
  • Horizons Clinical Research Center, LLC
  • Dermatology Physicians of CT
  • Center for Clincial and Cosmetic Research
  • Florida Academic Centers Research & Education
  • Aby's New Generation Research Inc.
  • Health Awareness, Inc.
  • Finlay Medical Research
  • Floridian Research Institute
  • Pioneer Clinical Research
  • Radiant Research, Inc.
  • Health Awareness, Inc
  • International Clinical Research-US, LLC
  • Lenus Research & Medical Group
  • MOORE Clinical Research, Inc
  • Visions Clinical Research
  • Research Institute of the Southeast, LLC
  • Marietta Dermatology Clinical Research, Inc.
  • Arlington Dermatology
  • Forefront Dermatology
  • Kansas City Dermatology, PA
  • Skin Sciences, PLLC
  • Clinical Trials Management, LLC
  • DelRicht Research
  • Lawrence Jeffrey Green MD, LLC
  • Great Lakes Research Group, Inc
  • Henry Ford Medical Center, New Center One
  • Minnesota Clinical Study Center
  • Mercy Research
  • Meridian Clinical Research, LLC
  • Quality Clinical Research Inc.
  • Meridian Clinical Research
  • JDR Dermatology Research, LLC
  • Acne Treatment & Research Center
  • Schweiger Dermatology, PLLC
  • Skin Search of Rochester, Inc.
  • DermResearchCenter of New York, Inc.
  • Sterling Research Group
  • Cyn3rgy Research
  • Clinical Partners, LLC
  • Meridian Clincial Research
  • The Skin Wellness Center
  • International Clinical Research - Tennessee LLC
  • Clinical Research Associates, Inc.
  • Tennessee Clinical Research Center
  • DermResearch, Inc
  • Avant Research Associates
  • J&S Studies, Inc.
  • Synexus US, LP, dba, Research Across America
  • Suzanne Bruce and Associates, P.A. The Center for Skin Research
  • Austin Institute for Clinical Research, Inc
  • Synexus US, LP, dba, Research Across America
  • Progressive Clinical Research, PA
  • Clinical Trials of Texas, Inc.
  • Dermatology Clinical Research Center of San Antonio
  • Houston Center for Clinical Research
  • The Education & Research Foundation, Inc.
  • Virginia Clinical Research, Inc.
  • Premier Clinical Research
  • Woden Dermatology
  • Premier Specialists
  • St George Dermatology and Skin Cancer Centre
  • The Skin Centre
  • Veracity Clinical Research
  • North Eastern Health Specialists
  • Skin & Cancer Foundation Inc.
  • Sinclair Dermatology
  • Fremantle Dermatology
  • Burswood Dermatology
  • Institute for Skin Advancement
  • Enverus Medical Research
  • Wiseman Dermatology Research Inc.
  • SimcoDerm Medical and Surgical Dermatology Center
  • Lynderm Research Inc.
  • DermEdge Research
  • North Bay Dermatology Centre
  • The Centre for Dermatology
  • Research Toronto
  • XLR8 Medical Research
  • Windsor Research Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olumacostat Glasaretil Gel, 5.0%

Arm Description

Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face

Outcomes

Primary Outcome Measures

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

Secondary Outcome Measures

Full Information

First Posted
April 17, 2017
Last Updated
July 16, 2021
Sponsor
Dermira, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03127956
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermira, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olumacostat Glasaretil Gel, 5.0%
Arm Type
Experimental
Arm Description
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Intervention Type
Drug
Intervention Name(s)
Olumacostat Glasaretil Gel, 5.0%
Other Intervention Name(s)
DRM01B
Intervention Description
Gel containing Olumacostat Glasaretil
Primary Outcome Measure Information:
Title
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Description
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Time Frame
Day 1 - Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Zib
Organizational Affiliation
Dermira, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Avant Research Associates, LLC
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Advanced Research Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Alliance Dermatology & MOHS Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Dermatology Trial Associates
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Advanced Skincare Surgery & MedCenter
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
TCR Medical Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University Clinical Trials Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Radiant Research, Inc.
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Dermatology Physicians of CT
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Facility Name
Center for Clincial and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Florida Academic Centers Research & Education
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Aby's New Generation Research Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Floridian Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Pioneer Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Health Awareness, Inc
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
International Clinical Research-US, LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Lenus Research & Medical Group
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
MOORE Clinical Research, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Visions Clinical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Research Institute of the Southeast, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Marietta Dermatology Clinical Research, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Forefront Dermatology
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Kansas City Dermatology, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Lawrence Jeffrey Green MD, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Great Lakes Research Group, Inc
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Henry Ford Medical Center, New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Mercy Research
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Quality Clinical Research Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
JDR Dermatology Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Acne Treatment & Research Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Schweiger Dermatology, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
DermResearchCenter of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Meridian Clincial Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Avant Research Associates
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Synexus US, LP, dba, Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Suzanne Bruce and Associates, P.A. The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Synexus US, LP, dba, Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Houston Center for Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Premier Specialists
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
St George Dermatology and Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
North Eastern Health Specialists
City
Hectorville
State/Province
South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
Skin & Cancer Foundation Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
XLR8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Windsor Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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