Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Erythema
Intervention: Brimonidine; placebo
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: 462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to
      Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson
      Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33%
      (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema
      Associated with Rosacea
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female, 18 years of age or older.

          2. Signed informed consent form, which meets all criteria of current FDA regulations.

          3. Females of child bearing potential must not be pregnant or lactating at Screening and
             Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of
             less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of
             childbearing potential must agree to the use of a reliable method of contraception
             (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm
             with spermicide], oral, transdermal, injected or implanted non- or hormonal
             contraceptive), throughout the study. A sterile sexual partner is not considered an
             adequate form of birth control.

             All females will be considered to be of childbearing potential unless they:

               -  Are post-menopausal, defined as women who have been amenorrheic for at least 12
                  consecutive months, without other known or suspected primary cause.

               -  Have been sterilized surgically or who are otherwise proven sterile (i.e., total
                  hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to
                  Screening. Tubal ligation will not be considered a surgically sterile method.

             Female patients of childbearing potential are defined as:

               -  Women without prior hysterectomy, or who have had any evidence of menses in the
                  past 12 months.

               -  Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly
                  due to other causes, including prior chemotherapy, anti-estrogens, or ovarian
                  suppression.

          4. Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on
             the face at Screening and at Randomization (before drug application on Day 1).

          5. Have moderate to severe facial erythema according to both CEA and PSA (i.e., an
             erythema score of 3 or more for each of the CEA and PSA) at Screening and at
             Randomization (before drug application on Day 1).

          6. Free from any systemic or dermatologic disorder (other than rosacea) that, in the
             opinion of the Investigator, will interfere with the study evaluations or increase the
             risk of AEs.

          7. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hot
             environments, prolonged sun exposure, strong winds and emotional stress) within 24
             hours of the Screening and Randomization visit.

          8. Any skin type or race, providing the skin pigmentation will allow discernment of
             erythema.

          9. Willingness and capability to cooperate to the extent and degree required by the
             protocol.

        Exclusion Criteria:

          1. Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans,
             isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial
             dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks,
             and forehead), that in the opinion of the Investigator would interfere with study
             evaluations.

          2. Have 3 or more facial inflammatory lesions of rosacea.

          3. Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or
             the PSA at Screening and at Randomization (before drug application on Day 1).

          4. Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would
             interfere with the diagnosis or assessment of rosacea.

          5. Patients with moderate to severe telangiectasial masses in the 5 areas of the entire
             face: forehead, chin, nose and each cheek, that would interfere with study
             evaluations.

          6. History of hypersensitivity or allergy to Mirvaso® including the active ingredient
             brimonidine tartarate or other component within the formulation.

          7. Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to
             randomization.

          8. Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or
             randomization visit and/or patient was unwilling to refrain from excessive exposure to
             UV radiation during the course of the study.

          9. History of blood dyscrasia.

         10. 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, or any other
             condition causing uncontrolled blood flow or blood pressure.

         11. Females who are pregnant, lactating or likely to become pregnant during the study.

         12. Significant history or current evidence of chronic infectious disease, system
             disorder, organ disorder or other medical condition that in the Investigator's opinion
             would place the study patient at undue risk by participation.

         13. Patients with severe, unstable or uncontrolled cardiovascular disease.

         14. Patients who meet study restrictions at Screening and Randomization and/or
             unwillingness to comply with all restricted treatments

         15. Receipt of any drug as part of a research study within 30 days before dosing.

         16. Employees of the research center or Investigator.

         17. Previous participation in this study.

         18. Patients who are unable and/or unwilling to follow the study requirements, and
             procedures.