Title
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
Phase
Phase 2Lead Sponsor
GaldermaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
RosaceaIntervention/Treatment
brimonidine ...Study Participants
269The 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.
CD07805/47 Gel 0.5% QD
Vehicle Gel QD
CD07805/47 Gel 0.18% QD
CD07805/47 Gel 0.18% BID
Vehicle Gel BID
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.
| Event Type | Organ System | Event Term | CD07805/47 Gel 0.5% QD | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% BID | Vehicle Gel QD | Vehicle Gel BID |
|---|
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Amost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness / Very mild redness / Mild redness / Moderate redness / Severe redness
