Topical 5% Imiquimod Cream for Vulvar Paget's Disease

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Center Nijmegen
• Collaborators: Catharina Ziekenhuis Eindhoven; Erasmus Medical Center; Leiden University Medical Center; The Netherlands Cancer Institute; UMC Utrecht; University Medical Center Groningen
• Treatments: Acetaminophen; Imiquimod; Lidocaine; Petrolatum

Criteria

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.