Topical 5% Imiquimod Cream for Vulvar Paget's Disease

University Medical Center Nijmegen

Status and phase: Completed; Phase 3

Conditions: Paget Disease, Extramammary

Treatments: Drug: paracetamol; Drug: lidocaine in Vaseline ointment; Drug: Imiquimod

Study type: Interventional

Funder types: Other

Identifiers

NCT02385188

NL51648.091.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Imiquimod

Experimental group

Description:

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

Treatment:

Drug: lidocaine in Vaseline ointment

Drug: paracetamol

Drug: Imiquimod