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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Dermira, Inc.
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.
ClinicalTrials.gov Identifier:
NCT03073486
First received: March 3, 2017
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Acne Vulgaris Drug: Olumacostat Glasaretil Gel Other: Vehicle Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dermira, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 700
Actual Study Start Date: February 6, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Olumacostat Glasaretil Gel
Drug: Olumacostat Glasaretil Gel
Olumacostat Glasaretil Gel
Other Name: DRM01
Placebo Comparator: Treatment B
Vehicle
Other: Vehicle
Vehicle

  Eligibility

Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03073486

Contacts
Contact: Beth Zib 650-421-7210 beth.zib@dermira.com

  Show 46 Study Locations
Sponsors and Collaborators
Dermira, Inc.
Investigators
Study Director: Beth Zib Dermira, Inc.
  More Information

Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03073486     History of Changes
Other Study ID Numbers: DRM01B-ACN04
Study First Received: March 3, 2017
Last Updated: June 9, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on August 16, 2017