A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

Vyne Therapeutics

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle Foam; Drug: FMX-101, 4% minocycline foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02815280

FX2014-05

Details and patient eligibility

About

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Full description

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

Enrollment: 495 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has facial acne vulgaris with:

  • 20 to 50 inflammatory lesions (papules, pustules, and nodules)
  • 25 to 100 noninflammatory lesions (open and closed comedones)
  • No more than 2 nodules on the face
  • IGA score of moderate (3) to severe (4)

• Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

Exclusion criteria

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
• Sunburn on the face

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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495 participants in 2 patient groups, including a placebo group

FMX-101, 4% minocycline foam

Experimental group

Description:

FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

Treatment:

Drug: FMX-101, 4% minocycline foam

Vehicle Foam

Placebo Comparator group

Description:

Vehicle foam applied topically once daily for 12 weeks

Treatment:

Drug: Vehicle Foam