Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Paget Disease, Extramammary Clinical Trial

Official title: Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Paget Disease, Extramammary

• NCT number: NCT02385188
• Study type: Interventional
• Source: University Medical Center Nijmegen
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Completion date: November 2019