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

• Status: Completed
• Trial end date: 2018-04-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.

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