Spots Global Cancer Trial Database for Topical 5% Imiquimod Cream for Vulvar Paget's Disease

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Trial Identification

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 ID: NCT02385188

Conditions

Paget Disease, Extramammary

Interventions

Imiquimod

paracetamol

lidocaine in Vaseline ointment

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.