Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10

Conditions
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Rosacea, Papulopustular Rosacea

Intervention / Treatment
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* Drug: FMX-103 1.5%
* Drug: FMX-103 3%
* Drug: Vehicle foam (0%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants age is 18 years or older. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp. Subject must have diagnosed rosacea for at least 6 months prior to screening. Exclusion Criteria: History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema. Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome). Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment. Bacterial folliculitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX-103 1.5%<br>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. | Drug: FMX-103 1.5%<br>* 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.<br>* Other names: Minocycline foam 1.5%;|
| Experimental: FMX-103 3%<br>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. | Drug: FMX-103 3%<br>* 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.<br>* Other names: Minocycline foam 3%;|
| Placebo Comparator: Vehicle foam (0%)<br>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. | Drug: Vehicle foam (0%)<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the absolute change in inflammatory lesion count at Week 12 compared to Baseline. |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline. |  | Baseline to Week 12 |