Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Information source: University of Medicine and Dentistry New Jersey
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvar Cancer
Intervention: Ciclopirox (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Medicine and Dentistry New Jersey Official(s) and/or principal investigator(s):
Bernadette Cracchiolo, MD, MPH, Principal Investigator, Affiliation: University of Medicine and Dentistry New Jersey
Summary
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.
Clinical Details
Official title: Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): 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.
Locations and Contacts
University of Medicine and Dentistry of NJ, Newark, New Jersey 07107, United States; Recruiting
Moumita Chakraborty, BS, Phone: 973-972-7789, Email: chakramo@umdnj.edu
Tracie Saunders, RN, MS, Phone: 973-972-7789, Email: saundetk@umdnj.edu
Bernadette Cracchiolo, MD, MPH, Principal Investigator
Additional Information
Last updated: September 27, 2006
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