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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
Last Updated

September 6, 2013

Status Verified

April 1, 2013

First QC Date

September 27, 2006

Last Update Submit

September 5, 2013

Conditions

Vulvar Cancer

Keywords

Vulva

Interventions

CiclopiroxDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Dentistry of NJ

Newark, New Jersey, 07107, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Ciclopirox

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bernadette Cracchiolo, MD, MPH

    University of Medicine and Dentistry of New Jersey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Last Updated

September 6, 2013

Record last verified: 2013-04

Locations

US(1)