Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
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...
Brief Summary
Official Title: “Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Ciclopirox
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Clinical Trial Investigator Information
Lead Investigator: University of Medicine and Dentistry New Jersey Other
Overall Clinical Trial Officials and Contacts
Bernadette Cracchiolo, MD, MPH Principal Investigator University of Medicine and Dentistry New Jersey
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00382330
Study ID Number: 0120050348
ClinicalTrials.gov Identifier: NCT00382330
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00382330
