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: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Ciclopirox

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

Lead Sponsor: University of Medicine and Dentistry New Jersey

Overall Clinical Trial Officials and Contacts

Bernadette Cracchiolo, MD, MPH Principal Investigator University of Medicine and Dentistry New Jersey  

Information obtained from ClinicalTrials.gov on September 05, 2008

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