Dose Response Study of Patients With Erythematous Rosacea
- Registration Number
- NCT01186068
- Lead Sponsor
- Vicept Therapeutics, Inc.
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle vehicle Cream without an active ingredient V-101 Cream 0.01% Concentration V-101 Low dose V-101 Cream 0.06% Concentration V-101 Mid-dose V-101 Cream 0.1% Concentration V-101 Mid-dose V-101 Cream 0.15% Concentration V-101 High dose
- Primary Outcome Measures
Name Time Method Clinician's Erythema Assessment Day 28 visit Physician visual evaluation
- Secondary Outcome Measures
Name Time Method Subject's Self Assessment 28 Day Visit Patient assesses their condition
Trial Locations
- Locations (7)
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
Baumann Cosmetic & Research Institute
🇺🇸Miami Beach, Florida, United States
DBA Michigan Center for Skin Care Research
🇺🇸Clinton Twp, Michigan, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States