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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Vulvar Cancer

Keywords

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Vulva

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Ciclopirox

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernadette Cracchiolo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Dentistry of New Jersey

Locations

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University of Medicine and Dentistry of NJ

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0120050348

Identifier Type: -

Identifier Source: org_study_id