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Dose Response Study of Patients With Erythematous Rosacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186068
First Posted: August 20, 2010
Last Update Posted: November 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Accenture
Information provided by:
Vicept Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Erythematous (Type One) Rosacea Drug: V-101 Other: vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea

Resource links provided by NLM:


Further study details as provided by Vicept Therapeutics, Inc.:

Primary Outcome Measures:
  • Clinician's Erythema Assessment [ Time Frame: Day 28 visit ]
    Physician visual evaluation


Secondary Outcome Measures:
  • Subject's Self Assessment [ Time Frame: 28 Day Visit ]
    Patient assesses their condition


Estimated Enrollment: 175
Study Start Date: August 2010
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186068


Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
Baumann Cosmetic & Research Institute
Miami Beach, Florida, United States, 33140
United States, Kentucky
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
United States, Michigan
DBA Michigan Center for Skin Care Research
Clinton Twp, Michigan, United States, 48038
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Vicept Therapeutics, Inc.
Accenture
Investigators
Principal Investigator: Stacy R Smith, MD Therapeutics Clinical Research
Principal Investigator: Michael T Jarratt, MD DermResearch, Inc
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
  More Information

Responsible Party: Chief Operating Officer, Vicept Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01186068     History of Changes
Other Study ID Numbers: V-101-ROSE-202
First Submitted: August 17, 2010
First Posted: August 20, 2010
Last Update Posted: November 24, 2010
Last Verified: August 2010

Keywords provided by Vicept Therapeutics, Inc.:
Rosacea, erythema

Additional relevant MeSH terms:
Rosacea
Skin Diseases