Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Inclusion Criteria:

• Male or female, who is at least 18 years of age or older.
• A clinical diagnosis of rosacea.
• A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

• Three (3) or more facial inflammatory lesions.
• 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.
• Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
• Intraocular pressure (IOP) measurement less than 10 mm Hg.