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

Tracking Information

First Received Date ^ICMJE

September 27, 2006

Last Updated Date

April 24, 2013

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00382330 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Vulvar Cancer

Intervention ^ICMJE

Drug: Ciclopirox

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

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

Not Provided

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00382330

Other Study ID Numbers ^ICMJE

0120050348

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Medicine and Dentistry New Jersey

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Not Provided

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

April 2013

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

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