Status:

COMPLETED

Dose Response Study of Patients With Erythematous Rosacea

Lead Sponsor:

Vicept Therapeutics, Inc.

Collaborating Sponsors:

Accenture

Conditions:

Erythematous (Type One) Rosacea

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

175 Patients enrolled

Trial Details

Trial ID

NCT01186068

Start Date

August 1 2010

Last Update

November 24 2010

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Therapeutics Clinical Research

San Diego, California, United States, 92123

2

Baumann Cosmetic & Research Institute

Miami Beach, Florida, United States, 33140

3

Dermatology Specialists Research

Louisville, Kentucky, United States, 40202

4

DBA Michigan Center for Skin Care Research

Clinton Twp, Michigan, United States, 48038