Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Ivermectin; Ivermectin (reference); Placebo
Intervention MeSH terms: Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 486.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and efficacy of Perrigo's product to an
      FDA approved product for the treatment of inflammatory lesions rosacea
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must sign an Institutional Review Board (IRB) approved written informed consent for
             this study.

          2. Must be at least 18 years of age

          3. Must have a definite clinical diagnosis of moderate to severe facial papulopustular
             rosacea

          4. Subjects must be willing and able to understand and comply with the requirements of
             the study and apply the medication as instructed.

          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. History of hypersensitivity or allergy to the study medication and/or any ingredient
             in the study medication.

          5. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit
             1/Day 1 (Baseline).

          6. Current use of anticoagulation therapy and use throughout the study.

          7. Use of medicated make-up (including anti-aging make-up) throughout the study

          8. 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).

          9. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical
             antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.

         10. Use of medicated cleansers on the face (throughout the study.

         11. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements

         12. Use of topical astringents or abrasives, medicated topical preparations (prescription
             and OTC products) within 2 days prior to Visit 1 and throughout the study.

         13. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure
             (swimming etc.) within 24 hours of all study visits.

         14. 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.

         15. Previous enrollment in this study or current enrollment in this study at another
             participating site.

         16. 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.

         17. Subjects who in the opinion of the investigator, are unlikely to be able to follow the
             restrictions of the protocol and complete the study