A randomised, double-blind, placebo-controlled study to evaluate the efficacy of imiquimod 5% in women with Vulvar Intraepithelial Neoplasia (VIN) 2 and 3.
Completed
- Conditions
- 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.
- Registration Number
- NL-OMON20043
- Lead Sponsor
- niversity and governmental budget (90%), and a small unrestricted research grand from 3M Nederland (10%) and studymedication with randomizationcode.
- Brief Summary
Engl J Med. 2008 Apr 3;358(14):1465-73.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
1. Histologically proven, multifocal VIN 2 or 3 without invasion;
2. age of 18 and older;
Exclusion Criteria
1. Pregnancy;
2. (micro-)invasive carcinoma;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method