Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face

Inclusion Criteria

• Subject must sign an Institutional Review Board (IRB) approved written informed consent for this study.
• Subjects must be at least 18 years of age.
• Subjects must have a definite clinical diagnosis of moderate to facial papulopustular rosacea,
• Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other
• 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
• Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in judgment of the Investigator, would put the subject at undue risk or might confound the study assessments
• Currently using any product containing Azelaic Acid/or belonging to the same family as Azelaic Acid foam, 15%.
• Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout the study.
• History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, 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.