NCT01186068CompletedPhase 2
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vicept Therapeutics, Inc.
- Enrollment
- 175
- Locations
- 7
- Primary Endpoint
- Clinician's Erythema Assessment
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
V-101 Cream 0.01% Concentration
Experimental
Low dose
Intervention: V-101 (Drug)
V-101 Cream 0.06% Concentration
Experimental
Mid-dose
Intervention: V-101 (Drug)
V-101 Cream 0.1% Concentration
Experimental
Mid-dose
Intervention: V-101 (Drug)
V-101 Cream 0.15% Concentration
Experimental
High dose
Intervention: V-101 (Drug)
Vehicle
Placebo Comparator
Cream without an active ingredient
Intervention: vehicle (Other)
Outcomes
Primary Outcomes
Clinician's Erythema Assessment
Time Frame: Day 28 visit
Physician visual evaluation
Secondary Outcomes
- Subject's Self Assessment(28 Day Visit)
Investigators
Study Sites (7)
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