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A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris (NCT03028363)

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
  • Drug: Olumacostat Glasaretil Gel
    • DRM01
  • Other: Vehicle
    Ages eligible for Study
    9 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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

    49 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    26 December, 2016
    Updated:
    08 June, 2017
    Participants:
    700
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