A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Dermira

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Olumacostat Glasaretil Gel, 5.0%; Other: Olumacostat Glasaretil Gel, Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03028363

DRM01B-ACN03

Details and patient eligibility

About

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

Enrollment: 759 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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759 participants in 2 patient groups, including a placebo group

Olumacostat Glasaretil Gel, 5.0%

Experimental group

Description:

Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks

Treatment:

Drug: Olumacostat Glasaretil Gel, 5.0%

Olumacostat Glasaretil Gel, Vehicle

Placebo Comparator group

Description:

Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Treatment:

Other: Olumacostat Glasaretil Gel, Vehicle