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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385188
• Other study ID #: NL51648.091.14
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: November 2019

Study information

• Verified date: December 2019
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paget Disease, Extramammary

Intervention

Drug:
• Imiquimod
topical 5% imiquimod cream 3 times a week for 16 weeks.
• paracetamol

• lidocaine in Vaseline ointment

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (7)

Lead Sponsor	Collaborator
University Medical Center Nijmegen	Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Leiden University Medical Center, The Netherlands Cancer Institute, UMC Utrecht, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	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.	12 weeks after the end of treatment
Secondary	Tolerability questionnaire	Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions: Have you used paracetamol during treatment?; How many days?; What dosage?; Was the use sufficient?; Have you used lidocaine in Vaseline ointment during treatment?; How many days?; What dosage?; Was the use sufficient?; Have you stopped the treatment with imiquimod because of side effects/pain?	4, 10 and 16 weeks after the start of treatment
Secondary	Adverse events	Most common adverse events will be evaluated with the following questions: Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.; Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.; 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.	4, 10 and 16 weeks after the start of treatment
Secondary	Immunological response	Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of	Baseline, 4 and 28 weeks after start of treatment
Secondary	Quality of life: general.	The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.	Baseline, 4 and 28 weeks after start of treatment.
Secondary	Quality of life: dermatology specific.	The questionnaire DLQI (Dermatology Life Quality Index) will be used.	Baseline, 4 and 28 weeks after start of treatment.
Secondary	Quality of life: sexuality.	The questionnaire FSDS (Female Sexual Distress Scale) will be used.	Baseline, 4 and 28 weeks after start of treatment.