An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea
Condition: Rosacea; Erythema
MeSH terms: Rosacea; Erythema
Intervention: Oxymetazoline
Intervention description: RLD
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      the study will measure the decrease in redness on the face of rosacea subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female, 18 years of age or older.

          2. Signed informed consent form that meets all criteria of current Food and Drug
             Administration regulations.

          3. Females of childbearing potential must not be pregnant or lactating.

          4. Females of childbearing potential must agree to the use of a reliable method of
             contraception throughout the study.

          5. Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.

          6. Have < 3 inflammatory lesions on the face.

          7. Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that
             is reflective of the overall targeted areas.

          8. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy
             foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional
             stress and alcoholic beverages) during the study.

        Exclusion Criteria:

          1. Forms of rosacea that, in the opinion of the Investigator, would interfere with the
             diagnosis or assessment of study endpoints

          2. Patient has a skin condition that, in the opinion of the Investigator, would interfere
             with the diagnosis or assessment of rosacea

          3. Patients with active sunburn or excessive facial hair such as beards, sideburns,
             moustaches, etc.

          4. Patients with moderate to severe telangiectasial masses

          5. History of blood dyscrasia.

          6. Significant history or current evidence of any uncontrolled chronic or serious disease
             or medical condition that would, in the judgment of the Investigator, would put the
             subject at undue risk or compromise the study assessments.

          7. History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled
             cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or
             hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or
             hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or
             narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would
             place the subject at undue risk.

          8. Female patients taking hormonal contraceptives or oral estrogen for less than one
             month or those that plan to change the dosage regimen during the course of the study.

          9. Previous participation in this study.

         10. Employees of the Investigator or research center or their immediate family members.

         11. Inability to understand the requirements of the study and the relative information and
             are unable or not willing to comply with the study protocol.