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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.

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 23, 2017
Results First Submitted Date  ICMJE November 28, 2018
Results First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE December 27, 2016
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Mean absolute change in acne lesion counts (inflammatory and non-inflammatory lesions) from baseline to Week 12 [ Time Frame: Week 12 ]
  • Proportion 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: Week 12 ]
Change History Complete list of historical versions of study NCT03028363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Percent change in acne lesion counts (inflammatory and non-inflammatory lesions) from baseline to Week 12 [ Time Frame: Week 12 ]
  • Proportion of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Official Title  ICMJE A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Olumacostat Glasaretil Gel, 5.0%
    Gel containing Olumacostat Glasaretil
    Other Name: DRM01
  • Other: Olumacostat Glasaretil Gel, Vehicle
    Vehicle (placebo) gel
Study Arms  ICMJE
  • Experimental: Olumacostat Glasaretil Gel, 5.0%
    Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
    Intervention: Drug: Olumacostat Glasaretil Gel, 5.0%
  • Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle
    Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
    Intervention: Other: Olumacostat Glasaretil Gel, Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
759
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2017)
700
Actual Study Completion Date  ICMJE November 28, 2017
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03028363
Other Study ID Numbers  ICMJE DRM01B-ACN03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dermira, Inc.
Study Sponsor  ICMJE Dermira, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beth Zib Dermira, Inc.
PRS Account Dermira, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP