Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid foam; Azelaic acid foam; Azelaic acid foam - Placebo
Intervention MeSH terms: Azelaic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the
      treatment of Inflammatory Lesions of Rosacea
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Subjects must be at least 18 years of age.

          3. Subjects must have a definite clinical diagnosis of moderate to facial papulopustular
             rosacea,

          4. 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

          5. Subjects must be in general good health and free from any clinically significant
             disease, other than rosacea, that might interfere with the study evaluations.

          6. 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:

          1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period
             of their study participation.

          2. Current or past ocular rosacea

          3. Presence of any other facial skin condition that might interfere with rosacea
             diagnosis and/or assessment

          4. 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

          5. Currently using any product containing Azelaic Acid/or belonging to the same family as
             Azelaic Acid foam, 15%.

          6. Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout
             the study.

          7. History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, and/or
             any ingredient in the study medication.

          8. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit
             1/Day 1 (Baseline).

          9. Current use of anticoagulation therapy and use throughout the study.

         10. Use of medicated make-up (including anti-aging make-up) throughout the study

         11. 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).

         12. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical
             antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.

         13. Use of medicated cleansers on the face throughout the study.

         14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements

         15. Use of topical astringents or abrasives, medicated topical preparations (prescription
             and OTC products) within 2 days prior to Visit 1 and throughout the study.

         16. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure
             (swimming etc.) within 24 hours of all study visits.

         17. 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.

         18. Previous enrollment in this study or current enrollment in this study at another
             participating site.

         19. 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.

         20. Subjects who in the opinion of the investigator, are unlikely to be able to follow the
             restrictions of the protocol and complete the study.