The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea. The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. Approximately 210 patients will participate in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
233
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
Time frame: Baseline to Week 12
The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
Time frame: Baseline to Week 12
Percent change in inflammatory lesion count at Week 12 compared to Baseline
Time frame: Baseline to Week 12
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
Time frame: Baseline to Week 12
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Unnamed facility
Berlin, Germany
Unnamed facility
Blaubeuren Abbey, Germany
Unnamed facility
Bochum, Germany
Unnamed facility
Buxtehude, Germany
Unnamed facility
Darmstadt, Germany
Unnamed facility
Dülmen, Germany
Unnamed facility
Düsseldorf, Germany
...and 10 more locations