Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
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.
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.
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.