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

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

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.

Inclusion Criteria:

1. Participants age is 18 years or older.
2. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
3. Subject must have diagnosed rosacea for at least 6 months prior to screening.

Exclusion Criteria:

1. History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
2. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
3. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
4. 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).
5. 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.
6. Bacterial folliculitis.