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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Olumacostat Glasaretil Gel, 5.0%

• Registration Number: NCT03127956
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-21
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Results First Submitted: 2018-12-20
• Results First Submitted QC: 2019-02-01
• Results First Posted: 2019-02-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 748

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions	Day 1 - Week 36	Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

Trial Locations

Locations (92)

Avant Research Associates, LLC; 🇺🇸 Guntersville, Alabama, United States

Advanced Research Associates; 🇺🇸 Glendale, Arizona, United States

Alliance Dermatology & MOHS Center; 🇺🇸 Phoenix, Arizona, United States

Dermatology Trial Associates; 🇺🇸 Bryant, Arkansas, United States

Northwest Arkansas Clinical Trials Center; 🇺🇸 Rogers, Arkansas, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Advanced Skincare Surgery & MedCenter; 🇺🇸 Fullerton, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

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