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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rosacea

Intervention / Treatment
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* Drug: CD07805/47 Gel
* Drug: Vehicle Gel
* Drug: CD07805/47 Gel
* Drug: CD07805/47 Gel
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD07805/47 Gel 0.5% QD<br> | Drug: CD07805/47 Gel<br>* CD07805/47 Gel 0.5% QD<br>|
| Experimental: CD07805/47 Gel 0.18% QD<br> | Drug: CD07805/47 Gel<br>* CD07805/47 Gel 0.18% QD<br>|
| Experimental: CD07805/47 Gel 0.18% BID<br> | Drug: CD07805/47 Gel<br>* CD07805/47 Gel 0.18% BID<br>|
| Placebo Comparator: Vehicle Gel QD<br> | Drug: Vehicle Gel<br>* Vehicle Gel QD<br>|
| Placebo Comparator: Vehicle Gel BID<br> | Drug: Vehicle Gel<br>* Vehicle Gel BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Success | 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. | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEA Success | 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 | Day 29 | 
| PSA-5 Success | 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 | day 29 |