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Dose Response Study of Patients With Erythematous Rosacea

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ClinicalTrials.gov Identifier: NCT01186068
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : November 24, 2010
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
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
Study Start Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: V-101 Cream 0.01% Concentration
Low dose
Drug: V-101
Cream QD
Experimental: V-101 Cream 0.06% Concentration
Drug: V-101
Cream QD
Experimental: V-101 Cream 0.1% Concentration
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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.
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 Posted: August 20, 2010    Key Record Dates
Last Update Posted: November 24, 2010
Last Verified: August 2010

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

Additional relevant MeSH terms:
Skin Diseases