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Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

NCT01861535 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-04-14

No results posted yet for this study

Summary

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

Conditions

  • Vulvar Intraepithelial Neoplasia

Interventions

DRUG

Imiquimod

PROCEDURE

Surgery

Sponsors & Collaborators

  • Austrian Science Fund (FWF)

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Gerda Trutnovsky, MD · Medical University of Graz

  • Karl Tamussino, MD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861535 on ClinicalTrials.gov