Dose Response Study of Patients With Erythematous Rosacea

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.

Detailed Description
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Patients must have moderate to severe erythematous (facial redness) rosacea Male and female patients must be at least 18 years old and in good general health Female patients must not be pregnant or nursing

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea

Conditions
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Erythematous (Type One) Rosacea

Intervention / Treatment
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* Drug: V-101
* Other: vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or females at least 18 years of age diagnosis of stable erythematous rosacea < 3 inflammatory lesions in good general health females must be non-pregnant and non-lactating must be willing to sign a consent form Exclusion Criteria: have ocular, phymatous or other types of rosacea allergy to any ingredient in study drug participation in other investigational studies within 30 days of enrollment use of systemic steroids within 28 days of Baseline use of tetracycline antibiotics within 28 days of baseline use of products containing oxymetazoline within 14 days of baseline use of topical steroids witin treatment area 14 days prior to baseline use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline use of any product for reducing redness within the treatment area witin 14 days prior to baseline use of monoamine oxidase (MAO) inhibitors use of niacin >/= 500mg/day

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: V-101 Cream 0.01% Concentration<br>Low dose | Drug: V-101<br>* Cream QD<br>|
| Experimental: V-101 Cream 0.06% Concentration<br>Mid-dose | Drug: V-101<br>* Cream QD<br>|
| Experimental: V-101 Cream 0.1% Concentration<br>Mid-dose | Drug: V-101<br>* Cream QD<br>|
| Experimental: V-101 Cream 0.15% Concentration<br>High dose | Drug: V-101<br>* Cream QD<br>|
| Placebo Comparator: Vehicle<br>Cream without an active ingredient | Other: vehicle<br>* Cream QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician's Erythema Assessment | Physician visual evaluation | Day 28 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Self Assessment | Patient assesses their condition | 28 Day Visit | 

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