Dose Response Study of Patients With Erythematous Rosacea - Full Text View

Sponsor:	Vicept Therapeutics, Inc.
Collaborator:	Octagon Research Solutions, Inc.
Information provided by:	Vicept Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01186068

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

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

Primary Outcome Measures:

Clinician's Erythema Assessment [ Time Frame: Day 28 visit ] [ Designated as safety issue: No ]
Physician visual evaluation

Secondary Outcome Measures:

Subject's Self Assessment [ Time Frame: 28 Day Visit ] [ Designated as safety issue: No ]
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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.

Octagon Research Solutions, Inc.

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

No publications provided

Responsible Party:	Chief Operating Officer, Vicept Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01186068 History of Changes
Other Study ID Numbers:	V-101-ROSE-202
Study First Received:	August 17, 2010
Last Updated:	November 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vicept Therapeutics, Inc.:

Rosacea, erythema

Additional relevant MeSH terms:

Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012