Topical 5% Imiquimod Cream for Vulvar Paget's Disease

December 30, 2019 updated by: Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen

Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response

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.

Study Overview

Detailed Description

Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.

The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amsterdam, Netherlands, 1066CX
        • Netherlands Cancer Institute
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis Eindhoven
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen
      • Leiden, Netherlands, 2333ZA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, 6525HB
        • Radboudumc
      • Rotterdam, Netherlands, 3000CA
        • Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Centre Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery;
  • Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.

Exclusion Criteria:

  • Invasive vulvar Paget's disease;
  • Underlying adenocarcinoma;
  • Treatment of the vulva with topical 5% imiquimod cream during the last 6 months;
  • Participation in a study with another investigational product within 30 days prior to enrolment in this study;
  • Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol);
  • Patients with autoimmune disorders;
  • Immune compromised patients (e.g. HIV patients, patients with a history of transplantation);
  • Insufficient understanding of the Dutch or English language;
  • Pregnant women;
  • Lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
topical 5% imiquimod cream 3 times a week for 16 weeks.
Other Names:
  • Aldara

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 12 weeks after the end of treatment
Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.
12 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability questionnaire
Time Frame: 4, 10 and 16 weeks after the start of treatment

Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:

  1. Have you used paracetamol during treatment?

    1. How many days?
    2. What dosage?
    3. Was the use sufficient?
  2. Have you used lidocaine in Vaseline ointment during treatment?

    1. How many days?
    2. What dosage?
    3. Was the use sufficient?
  3. Have you stopped the treatment with imiquimod because of side effects/pain?
4, 10 and 16 weeks after the start of treatment
Adverse events
Time Frame: 4, 10 and 16 weeks after the start of treatment

Most common adverse events will be evaluated with the following questions:

  1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
  2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
  3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
4, 10 and 16 weeks after the start of treatment
Immunological response
Time Frame: Baseline, 4 and 28 weeks after start of treatment
Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Baseline, 4 and 28 weeks after start of treatment
Quality of life: general.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Baseline, 4 and 28 weeks after start of treatment.
Quality of life: dermatology specific.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
The questionnaire DLQI (Dermatology Life Quality Index) will be used.
Baseline, 4 and 28 weeks after start of treatment.
Quality of life: sexuality.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
The questionnaire FSDS (Female Sexual Distress Scale) will be used.
Baseline, 4 and 28 weeks after start of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paget Disease, Extramammary

Clinical Trials on paracetamol

3
Subscribe