A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

Dermira

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Olumacostat Glasaretil; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02431052

DRM01B-ACN02

Details and patient eligibility

About

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

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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420 participants in 5 patient groups, including a placebo group

Olumacostat Glasaretil Gel, Vehicle QD

Placebo Comparator group

Description:

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

Treatment:

Other: Vehicle

Olumacostat Glasaretil Gel, Vehicle BID

Placebo Comparator group

Description:

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

Treatment:

Other: Vehicle

Olumacostat Glasaretil Gel, 4.0% QD

Experimental group

Description:

Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks

Treatment:

Drug: Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 7.5% QD

Experimental group

Description:

Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks

Treatment:

Drug: Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 7.5% BID

Experimental group

Description:

Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks

Treatment:

Drug: Olumacostat Glasaretil