Topical 5% Imiquimod Cream for Vulvar Paget's Disease

Phase 3

Completed

• Conditions: Paget Disease, Extramammary
• Interventions: Drug: Imiquimod; Drug: paracetamol; Drug: lidocaine in Vaseline ointment

• Registration Number: NCT02385188
• Lead Sponsor: University Medical Center Nijmegen

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.

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Study Start: 2015-05
• Primary Completion: 2018-03
• Study Completion: 2019-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imiquimod	lidocaine in Vaseline ointment	Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Imiquimod	Imiquimod	Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Imiquimod	paracetamol	Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical response	12 weeks after the end of treatment	Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.

Secondary Outcome Measures

Name	Time	Method
Tolerability questionnaire	4, 10 and 16 weeks after the start of treatment	Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions: 1. Have you used paracetamol during treatment?; 1. How many days?; 2. What dosage?; 3. Was the use sufficient?; 2. Have you used lidocaine in Vaseline ointment during treatment?; 1. How many days?; 2. What dosage?; 3. Was the use sufficient?; 3. Have you stopped the treatment with imiquimod because of side effects/pain?
Adverse events	4, 10 and 16 weeks after the start of treatment	Most common adverse events will be evaluated with the following questions: 1. Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.; 2. Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.; 3. Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
Immunological response	Baseline, 4 and 28 weeks after start of treatment	Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Quality of life: general.	Baseline, 4 and 28 weeks after start of treatment.	The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Quality of life: sexuality.	Baseline, 4 and 28 weeks after start of treatment.	The questionnaire FSDS (Female Sexual Distress Scale) will be used.
Quality of life: dermatology specific.	Baseline, 4 and 28 weeks after start of treatment.	The questionnaire DLQI (Dermatology Life Quality Index) will be used.

Trial Locations

Locations (7)

Radboudumc; 🇳🇱 Nijmegen, Netherlands

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Catharina Ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands