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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03028363
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Olumacostat Glasaretil Gel, 5.0% Other: Olumacostat Glasaretil Gel, Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Drug: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Name: DRM01

Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Other: Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel




Primary Outcome Measures :
  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

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



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028363


  Show 49 Study Locations
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.
  Study Documents (Full-Text)

Documents provided by Dermira, Inc.:
Study Protocol  [PDF] October 6, 2016
Statistical Analysis Plan  [PDF] January 19, 2018


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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03028363     History of Changes
Other Study ID Numbers: DRM01B-ACN03
First Posted: January 23, 2017    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases