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Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

This study is currently recruiting participants.
Verified April 2013 by University of Medicine and Dentistry New Jersey
Sponsor:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00382330
First received: September 27, 2006
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.


Condition Intervention
Vulvar Cancer
 Drug: Ciclopirox

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Patients between the ages 18 and 75 years.
  • Patients may be carriers of the Human Immunodeficiency Virus (HIV).
  • Patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue sampling (biopsy-proven vulvar intraepithelial neoplasia grade II or III)
  • Patients must be able to come to University Hospital for their initial appointment in Gynecologic Oncology Clinic, and for the eight follow-up visits in that Clinic required by the protocol.

Exclusion Criteria:

  • Pregnant or patients who are breast feeding a baby.
  • Patients who have been diagnosed with a vaginal yeast infection.
  • Patients who have undergone prior surgery for precancerous lesion(s) of the vulva.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382330

Locations
United States, New Jersey
University of Medicine and Dentistry of NJ Recruiting
Newark, New Jersey, United States, 07107
Contact: Moumita Chakraborty, BS     973-972-7789     chakramo@umdnj.edu    
Contact: Tracie Saunders, RN, MS     973-972-7789     saundetk@umdnj.edu    
Principal Investigator: Bernadette Cracchiolo, MD, MPH            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Bernadette Cracchiolo, MD, MPH University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00382330     History of Changes
Other Study ID Numbers: 0120050348
Study First Received: September 27, 2006
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Vulva

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female
 Antineoplastic Agents
Ciclopirox
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013