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Completed

NCT Number: NCT01186068

Dose Response Study of Patients With Erythematous Rosacea

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Therapeutics Clinical Research, San Diego, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-101

Drug

Cream QD

Vehicle

Other

Cream QD

Primary outcomes

  1. Clinician's Erythema Assessment

    Time frame: Day 28 visit

    Physician visual evaluation

Secondary outcomes

  1. Subject's Self Assessment

    Time frame: 28 Day Visit

    Patient assesses their condition

Sponsors and collaborators

Lead sponsor

Vicept Therapeutics, Inc.

Industry

Collaborators

  • Accenture

Registry information

Official study title

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea

Important dates

Study start
2010
First posted
Aug 20, 2010
Registry last updated
Nov 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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