Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1488
Healthy volunteers: no

Brief summary:
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)

Detailed 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

Arms:
arm 1: FMX101, 4% minocycline foam applied topically once daily for 12 weeks arm 2: Vehicle foam applied topically once daily for 12 weeks

Interventions: intervention 1: FMX101 intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: FMX101, 4% minocycline foam intervention 2: Vehicle Foam

Protocol document:
Prot_000.pdf: 





SAP_001.pdf: