Mirvaso in Use Study
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Brimonidine
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to:

        1. assess the signs and symptoms of rosacea, including erythema, without treatment and
           during treatment with Mirvaso® gel

        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment

        3. gain a better understanding of the real-world use of Mirvaso® on the pattern and
           management of facial erythema of rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be 18 years of age or older at time of study consent.

          2. Subjects with a board certified dermatologist (BCD) clinical diagnosis of facial
             erythema of rosacea and eligible for treatment with Mirvaso® (brimonidine) topical
             gel, 0.33% per package insert.

          3. Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit
             1.

          4. Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1.

          5. Subjects must be willing and able to give written informed consent including
             photography consent. Consent and photo consent will be obtained prior to any study
             related procedures

          6. Females of childbearing potential with a negative urine pregnancy test (UPT) at Visit
             1 (prior to test article application) or females of non-childbearing potential (deemed
             as post-menopausal [absence of menstrual bleeding for at least 1 year prior to
             enrollment], hysterectomy or bilateral oophorectomy).

        Exclusion Criteria:

          1. Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans,
             isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial
             dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis,
             facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          2. Subjects with current diagnosis of Raynaud's syndrome, thromboangiitis obliterans,
             orthostatic hypotension, severe cardiovascular disease, cerebral or coronary
             insufficiency, renal or hepatic impairment, scleroderma, Sjogren's syndrome or
             depression.

          3. Subjects with previous refractive eye surgery such as photorefractive keratectomy,
             laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.

          4. Current treatment with monoamine oxidase inhibitors.

          5. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or
             alpha- agonists.

          6. Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants,
             cardiac glycosides, beta blockers or other antihypertensive agents.

          7. Subjects with any uncontrolled chronic or serious disease or medical condition that
             would normally prevent participation in a clinical study, or, in the judgment of the
             investigator, would put the subjects at undue risk, or might confound the study
             assessments (e.g., other dermatological diseases), or might interfere with the
             subjects' participation in the study, (e.g., planned hospitalization during the
             study).

          8. Subjects who have received, applied, or taken treatments with drugs, cosmetics or
             devices known to cause facial erythema and who are deemed ineligible by the
             investigator.

          9. Subjects with known allergies or sensitivities to any component of the study drug,
             including the active ingredient brimonidine tartrate label (refer to the package
             insert for Mirvaso® (brimonidine) topical gel, 0.33%).

         10. Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical
             and/or systemic) alpha adrenergic agonists.

         11. Subjects who are pregnant or breast-feeding or planning to become pregnant during the
             course of the study.

         12. Subjects exposed to excessive ultraviolet (UV) radiation within I week prior to
             baseline and/or subject was unwilling to refrain from excessive exposure to UV
             radiation during the course of the study.

         13. Subjects with the presence of a beard or excessive facial hair that would interfere
             with the study treatments or study assessments as deemed by the investigator, and
             refusal to remove beard or facial hair for duration of the study.

         14. Subjects with non-stable dose of current (last 60 days) use of prescription rosacea
             medications.

         15. Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.

         16. Study site staff, relatives of staff members, or other individuals who would have
             access to the clinical study protocol.

         17. Subjects with participation in any investigational study within 30 days of entry into
             this study or concomitantly with this study