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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
topical 5% imiquimod cream 3 times a week for 16 weeks.
Netherlands Cancer Institute
Amsterdam, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
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.
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Radboudumc
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
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.