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

University of Medicine and Dentistry of New Jersey

Status

Withdrawn

Conditions

Vulvar Cancer

Treatments

Drug: Ciclopirox

Study type

Interventional

Funder types

Other

Identifiers

NCT00382330

0120050348

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.