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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127956
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : February 5, 2019
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company ( Dermira, Inc. )

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Olumacostat Glasaretil Gel, 5.0% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Safety

Arm Intervention/treatment
Experimental: Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Drug: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Name: DRM01B




Primary Outcome Measures :
  1. Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions [ Time Frame: Day 1 - Week 36 ]
    Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127956


Locations
Show Show 94 study locations
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company ( Dermira, Inc. ):
Study Protocol  [PDF] April 24, 2017
Statistical Analysis Plan  [PDF] April 10, 2018

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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03127956    
Other Study ID Numbers: DRM01B-ACN05
First Posted: April 25, 2017    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: July 20, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases