Back to resultsChemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Primary Purpose
Vulvar Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ciclopirox
Sponsored by
About this trial
This is an interventional prevention trial for Vulvar Cancer focused on measuring Vulva
Eligibility 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.
Sites / Locations
- University of Medicine and Dentistry of NJ
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00382330
First Posted
September 27, 2006
Last Updated
September 5, 2013
Sponsor
University of Medicine and Dentistry of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT00382330
Brief Title
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Official Title
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
Vulva
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclopirox
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Cracchiolo, MD, MPH
Organizational Affiliation
University of Medicine and Dentistry of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Dentistry of NJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
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