Clinical trial NCT02385188: Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Official title: Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paget Disease, Extramammary
Keywords: Extramammary Paget's disease
Vulva
Genital, female
imiquimod
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: University Medical Center Groningen
name: Erasmus Medical Center
name: The Netherlands Cancer Institute
name: UMC Utrecht
name: Catharina Ziekenhuis Eindhoven
First posted: 2015-03-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinical response
timeFrame: 12 weeks after the end of treatment
Secondary outcomes:
measure: Tolerability questionnaire
timeFrame: 4, 10 and 16 weeks after the start of treatment
measure: Adverse events
timeFrame: 4, 10 and 16 weeks after the start of treatment
measure: Immunological response
timeFrame: Baseline, 4 and 28 weeks after start of treatment
measure: Quality of life: general.
timeFrame: Baseline, 4 and 28 weeks after start of treatment.
measure: Quality of life: dermatology specific.
timeFrame: Baseline, 4 and 28 weeks after start of treatment.
measure: Quality of life: sexuality.
timeFrame: Baseline, 4 and 28 weeks after start of treatment.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Joanne de Hullu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Linden M, van Hees CL, van Beurden M, Bulten J, van Dorst EB, Esajas MD, Meeuwis KA, Boll D, van Poelgeest MI, de Hullu JA. The Paget Trial: topical 5% imiquimod cream for noninvasive vulvar Paget disease. Am J Obstet Gynecol. 2022 Aug;227(2):250.e1-250.e8. doi: 10.1016/j.ajog.2022.04.012. Epub 2022 Apr 18.
citation: van der Linden M, Meeuwis K, van Hees C, van Dorst E, Bulten J, Bosse T, IntHout J, Boll D, Slangen B, van Seters M, van Beurden M, van Poelgeest M, de Hullu J. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease. JMIR Res Protoc. 2017 Sep 6;6(9):e178. doi: 10.2196/resprot.7503.