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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMX-103 1.5% | Experimental | 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. |
|
| FMX-103 3% | Experimental | 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. |
|
| Vehicle foam (0%) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX-103 1.5% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the absolute change in inflammatory lesion count at Week 12 compared to Baseline. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline | Baseline to Week 12 | |
| Percent change in inflammatory lesion count at Week 12 compared to Baseline | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Mrowietz, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 10783 | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29396702 | Derived | Mrowietz U, Kedem TH, Keynan R, Eini M, Tamarkin D, Rom D, Shirvan M. A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea. Am J Clin Dermatol. 2018 Jun;19(3):427-436. doi: 10.1007/s40257-017-0339-0. |
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|
|
| FMX-103 3% | Drug | 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. |
|
|
| Vehicle foam (0%) | Drug | 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 dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline. | Baseline to Week 12 |
| Berlin |
| 13055 |
| Germany |
| Berlin | 13086 | Germany |
| Berlin | 13507 | Germany |
| Blaubeuren Abbey | 89143 | Germany |
| Bochum | 44803 | Germany |
| Buxtehude | 21614 | Germany |
| Darmstadt | 64283 | Germany |
| Dülmen | 48249 | Germany |
| Düsseldorf | 40212 | Germany |
| Friedrichshafen | 88045 | Germany |
| Kiel | 24105 | Germany |
| Mahlow | 15831 | Germany |
| Mainz | 55131 | Germany |
| Osnabrück | 49078 | Germany |
| Schweinfurt | 97421 | Germany |
| Selters | 56242 | Germany |
| Stuttgart | 70178 | Germany |
| Stuttgart | 70499 | Germany |
| Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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