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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,488
FMX101, 4% minocycline foam
Vehicle Foam
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
A decrease in the inflammatory lesion count from Baseline to Week 12.
Time frame: 12 weeks
Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline
Time frame: 12 weeks
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time frame: 12 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Time frame: 9 weeks
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Time frame: 6 weeks
IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6
Time frame: 6 weeks
IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9
Time frame: 9 weeks
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