Trial | NCT01186068  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    175
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.
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 Started
Aug 31
2010
Last Update
Nov 24
2010
Estimate

Drug V-101

Cream QD

Other vehicle

Cream QD

V-101 Cream 0.01% Concentration Experimental

Low dose

V-101 Cream 0.06% Concentration Experimental

Mid-dose

V-101 Cream 0.1% Concentration Experimental

Mid-dose

V-101 Cream 0.15% Concentration Experimental

High dose

Vehicle Placebo Comparator

Cream without an active ingredient

Criteria 

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
No Results Posted