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Dose Response Study of Patients With Erythematous Rosacea

NCT ID: NCT01186068

Last Updated: 2010-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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

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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

Conditions

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Erythematous (Type One) Rosacea

Keywords

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Rosacea, erythema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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V-101 Cream 0.01% Concentration

Low dose

Group Type EXPERIMENTAL

V-101

Intervention Type DRUG

Cream QD

V-101 Cream 0.06% Concentration

Mid-dose

Group Type EXPERIMENTAL

V-101

Intervention Type DRUG

Cream QD

V-101 Cream 0.1% Concentration

Mid-dose

Group Type EXPERIMENTAL

V-101

Intervention Type DRUG

Cream QD

V-101 Cream 0.15% Concentration

High dose

Group Type EXPERIMENTAL

V-101

Intervention Type DRUG

Cream QD

Vehicle

Cream without an active ingredient

Group Type PLACEBO_COMPARATOR

vehicle

Intervention Type OTHER

Cream QD

Interventions

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V-101

Cream QD

Intervention Type DRUG

vehicle

Cream QD

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Accenture

INDUSTRY

Sponsor Role collaborator

Vicept Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Vicept Therapeutics, Inc.

Principal Investigators

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Stacy R Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Therapeutics Clinical Research

Michael T Jarratt, MD

Role: PRINCIPAL_INVESTIGATOR

Derm Research, PLLC

Leslie S Baumann, MD

Role: PRINCIPAL_INVESTIGATOR

Baumann Cosmetic & Research Institute

Joseph F Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists Research

Robert T Matheson, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Medical Research Center, PC

Daniel M Stewart, DO

Role: PRINCIPAL_INVESTIGATOR

DBA Michigan Center for Skin Care Research

Eduardo Tschen, MD

Role: PRINCIPAL_INVESTIGATOR

Academic Dermatology Associates

Locations

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Therapeutics Clinical Research

San Diego, California, United States

Site Status

Baumann Cosmetic & Research Institute

Miami Beach, Florida, United States

Site Status

Dermatology Specialists Research

Louisville, Kentucky, United States

Site Status

DBA Michigan Center for Skin Care Research

Clinton Twp, Michigan, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Oregon Medical Research Center, PC

Portland, Oregon, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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V-101-ROSE-202

Identifier Type: -

Identifier Source: org_study_id