- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Amsterdam, Netherlands, 1066CX
- Netherlands Cancer Institute
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Eindhoven, Netherlands, 5623 EJ
- Catharina Ziekenhuis Eindhoven
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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Leiden, Netherlands, 2333ZA
- Leiden University Medical Center
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Nijmegen, Netherlands, 6525HB
- Radboudumc
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Rotterdam, Netherlands, 3000CA
- Erasmus Medical Center
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Utrecht, Netherlands, 3584 CX
- University Medical Centre Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
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topical 5% imiquimod cream 3 times a week for 16 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response
Time Frame: 12 weeks after the end of treatment
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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.
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12 weeks after the end of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability questionnaire
Time Frame: 4, 10 and 16 weeks after the start of treatment
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Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:
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4, 10 and 16 weeks after the start of treatment
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Adverse events
Time Frame: 4, 10 and 16 weeks after the start of treatment
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Most common adverse events will be evaluated with the following questions:
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4, 10 and 16 weeks after the start of treatment
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Immunological response
Time Frame: Baseline, 4 and 28 weeks after start of treatment
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Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
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Baseline, 4 and 28 weeks after start of treatment
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Quality of life: general.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
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The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
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Baseline, 4 and 28 weeks after start of treatment.
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Quality of life: dermatology specific.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
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The questionnaire DLQI (Dermatology Life Quality Index) will be used.
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Baseline, 4 and 28 weeks after start of treatment.
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Quality of life: sexuality.
Time Frame: Baseline, 4 and 28 weeks after start of treatment.
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The questionnaire FSDS (Female Sexual Distress Scale) will be used.
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Baseline, 4 and 28 weeks after start of treatment.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joanne de Hullu, MD PhD, Radboud University Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neoplasms, Ductal, Lobular, and Medullary
- Paget Disease, Extramammary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Antipyretics
- Antineoplastic Agents
- Immunologic Factors
- Dermatologic Agents
- Membrane Transport Modulators
- Adjuvants, Immunologic
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Emollients
- Interferon Inducers
- Lidocaine
- Acetaminophen
- Imiquimod
- Petrolatum
Other Study ID Numbers
- NL51648.091.14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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