vulvar extramammary paget's disease
Conditions
Interventions
All patients use topical 5% imiquimod cream 3 times a week for 16 weeks. In
case of side effects patients are allowed to use lidocain ointment and/or
painkillers, or to adjust the frequency to 2 tim
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Non invasive vulvar Paget's disease, primary or recurrence after previous surgery - Age 18 and older
Exclusion criteria
Exclusion criteria: - invasive vulvar Paget's disease - underlying adenocarcinoma - previous treatment of the vulva with 5% imiquimod cream during the last 6 months - patients with autoimmune disorders - immune compromised patients - pregnant women - lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome is the clinical response to treatment with topical 5% imiquimod cream, defined as a complete remission, partial remission or no remission. Complete remission is defined as disappearance of the lesion and histological confirmation of disappearance. Partial remission is defined as decrease by *50% of total lesion size. No response is defined as | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is the safety of topical 5% imiquimod cream, assessed by recording all adverse events; immunological response will be assessed by different immunological markers (which are currently studied in a pilot trial) and the quality of life during treatment will be assessed by 3 questionnaires, EQ5D, DLQI and (if applicable) FSDS. | — |
Countries
Netherlands
Outcome results
None listed