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Completed

NCT Number: NCT03127956

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Woden Dermatology, Phillip, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olumacostat Glasaretil Gel, 5.0%

Drug

Gel containing Olumacostat Glasaretil

Other names: DRM01B

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dermira, Inc.

Industry

Registry information

Official study title

An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2017
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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