NCT01186068

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
Last Updated

November 24, 2010

Status Verified

August 1, 2010

First QC Date

August 17, 2010

Last Update Submit

November 22, 2010

Conditions

Erythematous (Type One) Rosacea

Keywords

Rosacea, erythema

Outcome Measures

Primary Outcomes (1)

  • Clinician's Erythema Assessment

    Physician visual evaluation

    Day 28 visit

Secondary Outcomes (1)

  • Subject's Self Assessment

    28 Day Visit

Study Arms (5)

V-101 Cream 0.01% Concentration

EXPERIMENTAL

Low dose

Drug: V-101

V-101 Cream 0.06% Concentration

EXPERIMENTAL

Mid-dose

Drug: V-101

V-101 Cream 0.1% Concentration

EXPERIMENTAL

Mid-dose

Drug: V-101

V-101 Cream 0.15% Concentration

EXPERIMENTAL

High dose

Drug: V-101

Vehicle

PLACEBO COMPARATOR

Cream without an active ingredient

Other: vehicle

Interventions

V-101DRUG

Cream QD

V-101 Cream 0.01% ConcentrationV-101 Cream 0.06% ConcentrationV-101 Cream 0.1% ConcentrationV-101 Cream 0.15% Concentration
vehicleOTHER

Cream QD

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Baumann Cosmetic & Research Institute

Miami Beach, Florida, 33140, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

DBA Michigan Center for Skin Care Research

Clinton Twp, Michigan, 48038, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

RosaceaErythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stacy R Smith, MD

    Therapeutics Clinical Research

    PRINCIPAL INVESTIGATOR

  • Michael T Jarratt, MD

    Derm Research, PLLC

    PRINCIPAL INVESTIGATOR

  • Leslie S Baumann, MD

    Baumann Cosmetic & Research Institute

    PRINCIPAL INVESTIGATOR

  • Joseph F Fowler, MD

    Dermatology Specialists Research

    PRINCIPAL INVESTIGATOR

  • Robert T Matheson, MD

    Oregon Medical Research Center, PC

    PRINCIPAL INVESTIGATOR

  • Daniel M Stewart, DO

    DBA Michigan Center for Skin Care Research

    PRINCIPAL INVESTIGATOR

  • Eduardo Tschen, MD

    Academic Dermatology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 20, 2010

Study Start

August 1, 2010

Last Updated

November 24, 2010

Record last verified: 2010-08

Locations

US(7)