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

This study is currently recruiting participants.

Verified by University of Medicine and Dentistry New Jersey, September 2006

First Received: September 27, 2006 No Changes Posted

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00382330

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

MedlinePlus related topics: Cancer Vulvar Cancer

Drug Information available for: Ciclopirox Ciclopirox olamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

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

Study ID Numbers:	0120050348
Study First Received:	September 27, 2006
Last Updated:	September 27, 2006
ClinicalTrials.gov Identifier:	NCT00382330 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Vulva

Study placed in the following topic categories:

Genital Diseases, Female
Ciclopirox
Clotrimazole
Vulvar Neoplasms
Miconazole
Antifungal Agents

Vulvar Cancer
Tioconazole
Genital Neoplasms, Female
Urogenital Neoplasms
Vulvar Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Antineoplastic Agents
Genital Neoplasms, Female
Urogenital Neoplasms
Pharmacologic Actions
Genital Diseases, Female
Neoplasms

Neoplasms by Site
Ciclopirox
Vulvar Neoplasms
Therapeutic Uses
Antifungal Agents
Vulvar Diseases

ClinicalTrials.gov processed this record on May 07, 2009