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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A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Official Title
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A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks 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 0.5%


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 facial rosacea. A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application). A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application). Exclusion Criteria: 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. 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. Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK). Current treatment with monoamine oxidase (MAO) inhibitors. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists. Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD07805/47 Gel 0.5%<br> | Drug: CD07805/47 gel 0.5%<br>* In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema / Almost clear; slight redness / Mild erythema; definite redness / Moderate erythema; marked redness / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1. | Over 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosacea