VIN is a premalignant disease of the vulvar skin from which an invasive carcinoma may develop. It affects mainly young women, and causes severe and longlasting symptoms, such as pruritis, vulvar pain and sexual dysfunction. The disease is often multifocal on the vulva, and strongly related to infection with HPV. Standard therapy nowadays comprises surgical removal of all visible lesions. However, recurrence rates are high.
Conditions
Interventions
After qualifying for study participation patients are randomly assigned to receive either 250mg of imiquimod 5% cream (Aldara, 3M Pharmaceuticals, St Paul, MN, USA) or 250mg of placebo cream. Dosing w
Sponsors
University and governmental budget (90%), and a small unrestricted research grand from 3M Nederland (10%) and studymedication with randomizationcode.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven, multifocal VIN 2 or 3 without invasion; 2. age of 18 and older; 3. reliable method of contraception throughout the study.
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. (micro-)invasive carcinoma; 3. history of vulvar cancer; 4. unifocal lesion; 5. any other treatment for VIN or anogenital warts within one month of start of trial; 6. hypersensitivity to any components of the cream; 7. history of psoriasis or other inflammatory dermatosis of the vulva; 8. immunodeficiency; 9. insufficient command of the Dutch or English language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in lesion size. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Histological regression; 2. clearance of HPV; 3. relief of clinical symptoms; 4. improvement of quality of life. | — |
Contacts
Public ContactM. Beurden, van
The Netherlands Cancer Institute, Department of Gynecology, Plesmanlaan 121
Outcome results
None listed