NCT02385188

Topical 5% Imiquimod Cream for Vulvar Paget's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Medical Center Nijmegen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Paget Disease, Extramammary

Interventions

Type	Name	Description
DRUG	Imiquimod	topical 5% imiquimod cream 3 times a week for 16 weeks.
DRUG	paracetamol
DRUG	lidocaine in Vaseline ointment

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-03-01
• Completion: 2019-11-01
• First posted: 2015-03-11
• Last updated: 2020-01-02

Locations

7 sites across 1 country: Netherlands