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

Sponsor
University of Medicine and Dentistry of New Jersey (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00382330
Collaborator
(none)
0
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    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

    Locations

    Site City State Country Postal Code
    1 University of Medicine and Dentistry of NJ Newark New Jersey United States 07107

    Sponsors and Collaborators

    • University of Medicine and Dentistry of New Jersey

    Investigators

    • Principal Investigator: Bernadette Cracchiolo, MD, MPH, University of Medicine and Dentistry of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Medicine and Dentistry of New Jersey
    ClinicalTrials.gov Identifier:
    NCT00382330
    Other Study ID Numbers:
    • 0120050348
    First Posted:
    Sep 29, 2006
    Last Update Posted:
    Sep 6, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by University of Medicine and Dentistry of New Jersey
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2013