Topical 5% Imiquimod Cream for Vulvar Paget's Disease

NCT02385188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-01-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.

Conditions

  • Paget Disease, Extramammary

Interventions

DRUG

Imiquimod

topical 5% imiquimod cream 3 times a week for 16 weeks.

DRUG

lidocaine in Vaseline ointment

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER
  • University Medical Center Groningen

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • The Netherlands Cancer Institute

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER
  • University Medical Center Nijmegen

    lead OTHER

Principal Investigators

  • Joanne de Hullu, MD PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-03-31
Completion
2019-11-30

Countries

  • Netherlands

Study Locations

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Entities

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 NCT02385188 on ClinicalTrials.gov