Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

Study Overview
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Brief Summary
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This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

Official Title
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Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea

Conditions
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Erythematotelangiectatic Rosacea

Intervention / Treatment
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* Drug: CD07805/47
* Drug: CD07805/47
* Drug: CD07805/47
* Drug: CD07805/47 placebo


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. Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline. PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline. Presence of 2 or fewer inflammatory facial lesions. Exclusion Criteria: History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression. History of refractive surgery such as photorefractive keratectomy. The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants. The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD07805/47 0.5% Topical Gel<br>0.5% Topical Gel | Drug: CD07805/47<br>* 0.5% Topical Gel<br>|
| Experimental: CD07805/47 0.18% Topical Gel<br>0.18% Topical Gel | Drug: CD07805/47<br>* 0.18% Topical Gel<br>|
| Experimental: CD07805/47 0.07% Topical Gel<br>0.07% Topical Gel | Drug: CD07805/47<br>* 0.07% Topical Gel<br>|
| Placebo Comparator: CD07805/47 Vehicle Topical Gel<br>Vehicle Topical Gel | Drug: CD07805/47 placebo<br>* Vehicle Topical Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. |  | Baseline and every hour for 12 hours following application | 

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