Paget Disease, Extramammary
Conditions
Keywords
Extramammary Paget's disease, Vulva, Genital, female, imiquimod
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.
Interventions
DRUGImiquimod
topical 5% imiquimod cream 3 times a week for 16 weeks.
DRUGparacetamol
DRUGlidocaine in Vaseline ointment
Sponsors
Leiden University Medical Center
University Medical Center Groningen
Erasmus Medical Center
The Netherlands Cancer Institute
UMC Utrecht
Catharina Ziekenhuis Eindhoven
University Medical Center Nijmegen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
| Immunological response | 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 |
| Tolerability questionnaire | 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? |
| Quality of life: dermatology specific. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire DLQI (Dermatology Life Quality Index) will be used. |
| Quality of life: sexuality. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire FSDS (Female Sexual Distress Scale) will be used. |
| Quality of life: general. | Baseline, 4 and 28 weeks after start of treatment. | The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used. |
Countries
Netherlands
Outcome results
None listed