Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea

Inclusion criteria

• Must sign an Institutional Review Board (IRB) approved written informed consent for this study.
• Must be at least 18 years of age
• Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea
• Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed.
• Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
• Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion criteria

• Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
• Current or past ocular rosacea.
• Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment.
• History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication.
• Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
• Current use of anticoagulation therapy and use throughout the study.
• Use of medicated make-up (including anti-aging make-up) throughout the study
• Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
• Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
• Use of medicated cleansers on the face (throughout the study.
• Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
• Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
• Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
• Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
• Previous enrollment in this study or current enrollment in this study at another participating site.
• Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
• Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study