Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.
Not Applicable
Withdrawn
- Conditions
- Vulvar Cancer
- Registration Number
- NCT00382330
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie ciclopirox's antineoplastic effects in vulvar precancerous lesions?
How does topical ciclopirox compare to standard-of-care chemopreventive agents for vulvar intraepithelial neoplasia?
Are there specific biomarkers predictive of response to ciclopirox in lower genital tract cancer prevention?
What adverse events are associated with prolonged topical ciclopirox application for vulvar cancer chemoprevention?
What combination therapies with ciclopirox are being explored for enhancing antineoplastic activity in vulvar dysplasia?
Trial Locations
- Locations (1)
University of Medicine and Dentistry of NJ
🇺🇸Newark, New Jersey, United States
University of Medicine and Dentistry of NJ🇺🇸Newark, New Jersey, United States