Clinical trial NCT01186068: Dose Response Study of Patients With Erythematous Rosacea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythematous (Type One) Rosacea
Keywords: Rosacea, erythema
Lead sponsor: Vicept Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Accenture
First posted: 2010-08-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Clinician's Erythema Assessment
timeFrame: Day 28 visit
Secondary outcomes:
measure: Subject's Self Assessment
timeFrame: 28 Day Visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Miami Beach
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Clinton Twp
country: United States
facility: DBA Michigan Center for Skin Care Research
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Therapeutics Clinical Research
name: Stacy R Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research, PLLC
name: Michael T Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baumann Cosmetic & Research Institute
name: Leslie S Baumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists Research
name: Joseph F Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Medical Research Center, PC
name: Robert T Matheson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DBA Michigan Center for Skin Care Research
name: Daniel M Stewart, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Dermatology Associates
name: Eduardo Tschen, MD
role: PRINCIPAL_INVESTIGATOR
References: