A Phase 3 interventional study of Imiquimod and paracetamol in Paget Disease, Extramammary, sponsored by University Medical Center Nijmegen. Completed at 7 sites in Netherlands. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by University Medical Center Nijmegen · Phase 3, Interventional, and Treatment
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.
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.
University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Drug: Imiquimod · Drug: paracetamol · Drug: lidocaine in Vaseline ointment
topical 5% imiquimod cream 3 times a week for 16 weeks.
Also known as: Aldara
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.
Time frame: 12 weeks after the end of treatment
Tolerability questionnaire
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?
Time frame: 4, 10 and 16 weeks after the start of treatment
Adverse events
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.
Time frame: 4, 10 and 16 weeks after the start of treatment
Immunological response
Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Time frame: Baseline, 4 and 28 weeks after start of treatment
Quality of life: general.
The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: dermatology specific.
The questionnaire DLQI (Dermatology Life Quality Index) will be used.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: sexuality.
The questionnaire FSDS (Female Sexual Distress Scale) will be used.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imiquimod
Paget Disease, Extramammary
University Medical Center Nijmegen