Overview

Dose Response Study of Patients With Erythematous Rosacea

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vicept Therapeutics, Inc.
Collaborator:
Accenture
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