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

Dermira

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Olumacostat Glasaretil Gel, 5.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03127956

DRM01B-ACN05

Details and patient eligibility

About

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

Enrollment: 748 patients

Sex: All

Ages: 9+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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748 participants in 1 patient group

Olumacostat Glasaretil Gel, 5.0%

Experimental group

Description:

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

Treatment:

Drug: Olumacostat Glasaretil Gel, 5.0%