NCT02385188

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

February 5, 2015

Last Update Submit

December 30, 2019

Conditions

Paget Disease, Extramammary

Keywords

Extramammary Paget's diseaseVulvaGenital, femaleimiquimod

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks after the end of treatment

Secondary Outcomes (6)

  • Tolerability questionnaire

    4, 10 and 16 weeks after the start of treatment

  • Adverse events

    4, 10 and 16 weeks after the start of treatment

  • Immunological response

    Baseline, 4 and 28 weeks after start of treatment

  • Quality of life: general.

    Baseline, 4 and 28 weeks after start of treatment.

  • Quality of life: dermatology specific.

    Baseline, 4 and 28 weeks after start of treatment.

  • +1 more secondary outcomes

Study Arms (1)

Imiquimod

EXPERIMENTAL

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

Drug: ImiquimodDrug: paracetamolDrug: lidocaine in Vaseline ointment

Interventions

ImiquimodDRUG

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

Also known as: Aldara
Imiquimod
paracetamolDRUG
Imiquimod
lidocaine in Vaseline ointmentDRUG
Imiquimod

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, 5623 EJ, Netherlands

Location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

Radboudumc

Nijmegen, 6525HB, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000CA, Netherlands

Location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 35447145DERIVED

  • 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.

    PMID: 28877863DERIVED

MeSH Terms

Conditions

Paget Disease, Extramammary

Interventions

ImiquimodAcetaminophenLidocaine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Joanne de Hullu, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 5, 2015

First Posted

March 11, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2018

Study Completion

November 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

NL(7)