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Completed

NCT Number: NCT03073486

A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle 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

The Skin Centre, Benowa, 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 and, for subjects under legal adult age, signed assent
  • Age ≥ 9 years
  • Clinical diagnosis of facial acne vulgaris defined as:
  • At least 20 inflammatory lesions, and
  • At least 20 non-inflammatory lesions, and
  • Investigator Global Assessment of 3 or greater

Exclusion criteria

  • Active cystic acne or acne conglobata, acne fulminans, and secondary acne
  • Two or more active nodulocystic lesions on the face
  • Clinically significant abnormal laboratory or ECG result
  • Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
  • Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
  • Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
  • Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
  • Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
  • Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
  • Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

Treatment and study plan

Olumacostat Glasaretil Gel, 5.0%

Drug

Gel containing Olumacostat Glasaretil

Other names: DRM01

Olumacostat Glasaretil Gel, Vehicle

Other

Vehicle (placebo) gel

Primary outcomes

  1. Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12

    Time frame: Baseline and Week 12

    Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12

  2. Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12

    Time frame: Baseline and Week 12

    Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

  3. Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12

    Time frame: Baseline and Week 12

    Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12

    Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions

    • - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion
    • - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
    • - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
    • - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions

Sponsors and collaborators

Lead sponsor

Dermira, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 8, 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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