A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil; Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared
      to vehicle in patients with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Male or non-pregnant, non-lactating females.

          -  Age ≥ 18 years.

          -  Clinical diagnosis of facial acne vulgaris defined as:

          -  At least 20 inflammatory lesions

          -  At least 20 non-inflammatory lesions

          -  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.

          -  Screening clinical chemistry or hematology laboratory value that is considered
             clinically significant, in the opinion of the Investigator.

          -  Abnormal findings on screening ECG, deemed clinically significant, by the
             Investigator.

          -  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.

          -  Subjects who are a poor medical risk because of other systemic diseases or active
             uncontrolled infections, in the opinion of the investigator.

          -  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 corticosteroids (use of intranasal and inhaled corticosteroids
             allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.

          -  Treatment with systemic antibiotics or systemic anti-acne drugs or systemic
             anti-inflammatory drugs within 4 weeks prior to Baseline.

          -  Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g.,
             tretinoin, tazarotene, adapalene).

          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy
             within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy
             started more than 12 weeks prior to Baseline must remain unchanged throughout the
             study. Hormonal therapies include, but are not limited to, estrogenic and
             progestational agents such as birth control pills.

          -  Prior use of androgen receptor blockers (such as spironolactone or flutamide).

          -  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 of Baseline.

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
             weeks or during the study.