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

Tracking Information

First Received Date ^ICMJE

September 27, 2006

Last Updated Date

September 27, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Vulvar Cancer

Intervention ^ICMJE

Drug: Ciclopirox

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00382330

Responsible Party

Study ID Numbers ^ICMJE

0120050348

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bernadette Cracchiolo, MD, MPH

University of Medicine and Dentistry New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP