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Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Primary Purpose

Paget Disease, Extramammary

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Imiquimod
paracetamol
lidocaine in Vaseline ointment
Sponsored by
University Medical Center Nijmegen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paget Disease, Extramammary focused on measuring Extramammary Paget's disease, Vulva, Genital, female, imiquimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Netherlands Cancer Institute
  • Catharina Ziekenhuis Eindhoven
  • University Medical Center Groningen
  • Leiden University Medical Center
  • Radboudumc
  • Erasmus Medical Center
  • University Medical Centre Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imiquimod

Arm Description

Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.

Outcomes

Primary Outcome Measures

Clinical response
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.

Secondary Outcome Measures

Tolerability questionnaire
Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions: Have you used paracetamol during treatment? How many days? What dosage? Was the use sufficient? Have you used lidocaine in Vaseline ointment during treatment? How many days? What dosage? Was the use sufficient? Have you stopped the treatment with imiquimod because of side effects/pain?
Adverse events
Most common adverse events will be evaluated with the following questions: Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. 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.
Immunological response
Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Quality of life: general.
The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Quality of life: dermatology specific.
The questionnaire DLQI (Dermatology Life Quality Index) will be used.
Quality of life: sexuality.
The questionnaire FSDS (Female Sexual Distress Scale) will be used.

Full Information

First Posted
February 5, 2015
Last Updated
December 30, 2019
Sponsor
University Medical Center Nijmegen
Collaborators
Leiden University Medical Center, University Medical Center Groningen, Erasmus Medical Center, The Netherlands Cancer Institute, UMC Utrecht, Catharina Ziekenhuis Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT02385188
Brief Title
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Official Title
Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Nijmegen
Collaborators
Leiden University Medical Center, University Medical Center Groningen, Erasmus Medical Center, The Netherlands Cancer Institute, UMC Utrecht, Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget Disease, Extramammary
Keywords
Extramammary Paget's disease, Vulva, Genital, female, imiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod
Arm Type
Experimental
Arm Description
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara
Intervention Description
topical 5% imiquimod cream 3 times a week for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Type
Drug
Intervention Name(s)
lidocaine in Vaseline ointment
Primary Outcome Measure Information:
Title
Clinical response
Description
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.
Time Frame
12 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Tolerability questionnaire
Description
Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions: Have you used paracetamol during treatment? How many days? What dosage? Was the use sufficient? Have you used lidocaine in Vaseline ointment during treatment? How many days? What dosage? Was the use sufficient? Have you stopped the treatment with imiquimod because of side effects/pain?
Time Frame
4, 10 and 16 weeks after the start of treatment
Title
Adverse events
Description
Most common adverse events will be evaluated with the following questions: Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily. 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.
Time Frame
4, 10 and 16 weeks after the start of treatment
Title
Immunological response
Description
Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Time Frame
Baseline, 4 and 28 weeks after start of treatment
Title
Quality of life: general.
Description
The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Time Frame
Baseline, 4 and 28 weeks after start of treatment.
Title
Quality of life: dermatology specific.
Description
The questionnaire DLQI (Dermatology Life Quality Index) will be used.
Time Frame
Baseline, 4 and 28 weeks after start of treatment.
Title
Quality of life: sexuality.
Description
The questionnaire FSDS (Female Sexual Distress Scale) will be used.
Time Frame
Baseline, 4 and 28 weeks after start of treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne de Hullu, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525HB
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000CA
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
35447145
Citation
van der Linden M, van Hees CL, van Beurden M, Bulten J, van Dorst EB, Esajas MD, Meeuwis KA, Boll D, van Poelgeest MI, de Hullu JA. The Paget Trial: topical 5% imiquimod cream for noninvasive vulvar Paget disease. Am J Obstet Gynecol. 2022 Aug;227(2):250.e1-250.e8. doi: 10.1016/j.ajog.2022.04.012. Epub 2022 Apr 18.
Results Reference
derived
PubMed Identifier
28877863
Citation
van der Linden M, Meeuwis K, van Hees C, van Dorst E, Bulten J, Bosse T, IntHout J, Boll D, Slangen B, van Seters M, van Beurden M, van Poelgeest M, de Hullu J. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease. JMIR Res Protoc. 2017 Sep 6;6(9):e178. doi: 10.2196/resprot.7503.
Results Reference
derived

Learn more about this trial

Topical 5% Imiquimod Cream for Vulvar Paget's Disease

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