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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01186068

Enrollment

175

Registered

2010-08-20

Start date

2010-08-31

Completion date

Unknown

Last updated

2010-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythematous (Type One) Rosacea

Keywords

Rosacea, erythema

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

Interventions

DRUGV-101

Cream QD

OTHERvehicle

Cream QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinician's Erythema Assessment	Day 28 visit	Physician visual evaluation

Secondary

Measure	Time frame	Description
Subject's Self Assessment	28 Day Visit	Patient assesses their condition

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026