Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Brimonidine Topical Gel, 0.33 percent (Perrigo); Brimonidine Topical Gel, 0.33 percent (Reference); Placebo gel
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved
      rosacea drug product in the treatment of facial erythema of rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide IRB approved written informed consent/assent.

          2. Male or non-pregnant female, ≥ 18 years of age.

          3. Diagnosis of rosacea with moderate to severe erythema on the face defined as: a score
             of ≥ 3 on the Clinician's Erythema Assessment (CEA) and a score of ≥ 3 on the
             Patient's Self-Assessment (PSA) on Visit 1/Day 1 (Baseline) prior to the first
             application of study medication at hour 0.

          4. Willing and able to understand and comply with the requirements of the study.

          5. 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 in addition to having a negative urine pregnancy
             test, must be willing to use an acceptable form of birth control during the study

        Exclusion Criteria:

          1. Females who are pregnant, breast feeding, or planning a pregnancy within the study
             participation period.

          2. Presence of three (3) or more facial inflammatory lesions of rosacea.

          3. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome or depression.

          4. Other facial conditions that in the Investigator's opinion might interfere with a
             rosacea diagnosis and/or assessment including but not limited to: acne conglobata,
             acne fulminans, rhinophyma, facial pustulosis of the chin, peri-oral dermatitis,
             demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus
             erythematosus, actinic keratosis, acne, dermatitis, psoriasis, squamous cell
             carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid
             folliculitis, or bacterial folliculitis .

          5. Any uncontrolled, chronic or serious disease or medical condition that would prevent
             participation in a clinical trial or, in the judgment of the Investigator, would put
             the subject at undue risk or might confound the study assessments (such as planned
             hospitalization during the study).

          6. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements.

          7. Excessive facial hair (such as beards, sideburns, moustaches, etc.) that would
             interfere with diagnosis or assessment of rosacea.

          8. History of hypersensitivity or allergy to any ingredient in the study medication.

          9. Previous enrollment in this study.

         10. Non-responders to prior treatment with topical brimonidine.

         11. Currently using any product containing brimonidine tartrate or oxymetazoline.

         12. Start or change of dose of hormonal treatments.

         13. Start or change of dose of tricyclic or tetracyclic antidepressants, cardio
             glycosides, beta blockers or calcium channel blockers or other anti-hypertensive
             agents 3 months (90 days) prior to baseline or throughout the study. Use of such
             therapy must remain constant during the study.

         14. Current treatment with or start of any of the following class of drugs: monoamine
             oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or
             alpha-agonists, medicines for psychosis, medicines for hyperactivity

         15. Use within 6 months (180 days) prior to baseline or during the study of oral retinoids
             or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins
             are allowed).

         16. Use within 12 weeks (84 days) prior to baseline or during the study of systemic
             immunomodulators

         17. Use of medicated make-up throughout the study and/or significant change in the use of
             consumer products within 4 weeks (28 days) of study entry and throughout the study.

         18. Participation in any clinical study involving an investigational product or device in
             the 4 weeks (28 days) prior to baseline or throughout the study.

         19. Use of following topicals on the face within 14 days prior to baseline or during the
             study of antibiotics and/or prescription anti-inflammatory agents including ophthalmic

         20. Over the counter (OTC) topical anti-acne medications 7 days prior to baseline

         21. Chronic, daily use of OTC anti-inflammatory medications for more than 7 days (does not
             include low-dose aspirin for cardiac prophylaxis), 7 days prior to baseline and
             throughout the study. Subjects may use acetaminophen for pain relief, as needed
             throughout the study.

         22. Use of tanning booths, sun lamps, sunbathing, phototherapy or excessive ultraviolet
             (UV) exposure to the sun 7 days prior to baseline and throughout the study.

         23. Use of Niacin ≥500 mg per day within 7 days of study start and throughout the study.

         24. Use of topical astringents or abrasives within 2 days of study start and throughout
             the study.

         25. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure
             (swimming, etc.) within 24 hours of all study visits (Visit 1 through Visit 3).