Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paget Disease, Extramammary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imiquimod

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

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

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

paracetamol

Intervention Type DRUG

lidocaine in Vaseline ointment

Intervention Type DRUG

Interventions

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Imiquimod

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

Intervention Type DRUG

paracetamol

Intervention Type DRUG

lidocaine in Vaseline ointment

Intervention Type DRUG

Other Intervention Names

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Aldara

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes