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Topical 5% Imiquimod Cream for Vulvar Paget's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02385188
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Leiden University Medical Center
University Medical Center Groningen
Erasmus Medical Center
The Netherlands Cancer Institute
UMC Utrecht
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Paget Disease, Extramammary Drug: Imiquimod Drug: paracetamol Drug: lidocaine in Vaseline ointment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Imiquimod
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Drug: Imiquimod
topical 5% imiquimod cream 3 times a week for 16 weeks.
Other Name: Aldara

Drug: paracetamol
Drug: lidocaine in Vaseline ointment



Primary Outcome Measures :
  1. Clinical response [ Time Frame: 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 :
  1. Tolerability questionnaire [ Time Frame: 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?

  2. Adverse events [ Time Frame: 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.

  3. Immunological response [ Time Frame: 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

  4. Quality of life: general. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.

  5. Quality of life: dermatology specific. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire DLQI (Dermatology Life Quality Index) will be used.

  6. Quality of life: sexuality. [ Time Frame: Baseline, 4 and 28 weeks after start of treatment. ]
    The questionnaire FSDS (Female Sexual Distress Scale) will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385188


Locations
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Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands, 5623 EJ
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Leiden University Medical Center
Leiden, Netherlands, 2333ZA
Radboudumc
Nijmegen, Netherlands, 6525HB
Erasmus Medical Center
Rotterdam, Netherlands, 3000CA
University Medical Centre Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
University Medical Center Nijmegen
Leiden University Medical Center
University Medical Center Groningen
Erasmus Medical Center
The Netherlands Cancer Institute
UMC Utrecht
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Joanne de Hullu, MD PhD Radboud University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joanne A. de Hullu, MD, PhD, MD PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT02385188    
Other Study ID Numbers: NL51648.091.14
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Keywords provided by Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen:
Extramammary Paget's disease
Vulva
Genital, female
imiquimod
Additional relevant MeSH terms:
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Paget Disease, Extramammary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Acetaminophen
Imiquimod
Lidocaine
Petrolatum
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents
Interferon Inducers
Emollients