A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

Vyne Therapeutics

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle Foam; Drug: FMX101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03271021

FX2017-22

Details and patient eligibility

About

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Full description

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

• FMX101 4% minocycline foam
• Vehicle foam

Enrollment: 1,488 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has facial acne vulgaris with:

   1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
   2. 25 to 100 non-inflammatory lesions (open and closed comedones)
   3. No more than 2 nodules on the face
   4. IGA score of moderate (3) to severe (4)

2. 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

1. 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.
2. Sunburn on the face.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,488 participants in 2 patient groups, including a placebo group

FMX101, 4% minocycline foam

Experimental group

Description:

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

Treatment:

Drug: FMX101

Vehicle foam

Placebo Comparator group

Description:

Vehicle foam applied topically once daily for 12 weeks

Treatment:

Drug: Vehicle Foam