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

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.

Study Overview

• Status: Completed
• Conditions: Erythematous (Type One) Rosacea
• Intervention / Treatment: Drug: V-101; Other: vehicle

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

• Study Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Baumann Cosmetic & Research Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Michigan
    • Clinton Twp, Michigan, United States, 48038
      • DBA Michigan Center for Skin Care Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, Pc
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-101 Cream 0.01% Concentration; Low dose	Drug: V-101; Cream QD
Experimental: V-101 Cream 0.06% Concentration; Mid-dose	Drug: V-101; Cream QD
Experimental: V-101 Cream 0.1% Concentration; Mid-dose	Drug: V-101; Cream QD
Experimental: V-101 Cream 0.15% Concentration; High dose	Drug: V-101; Cream QD
Placebo Comparator: Vehicle; Cream without an active ingredient	Other: vehicle; Cream QD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vicept Therapeutics, Inc.
• Collaborators: Accenture
• Investigators: Principal Investigator: Eduardo Tschen, MD, Academic Dermatology Associates; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2010

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): November 24, 2010
• Last Update Submitted That Met QC Criteria: November 22, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Rosacea, erythema
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: V-101-ROSE-202