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

Vulvar Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00382330
• Other study ID #: 0120050348
• Status: Withdrawn
• Phase: N/A
• First received: September 27, 2006
• Last updated: September 5, 2013

Study information

• Verified date: April 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• Ciclopirox

Locations

Country	Name	City	State
United States	University of Medicine and Dentistry of NJ	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States,