A randomised, double-blind, placebo-controlled study to evaluate the efficacy of imiquimod 5% in women with vulvar intraepithelial neoplasia (VIN) stages two and three
Completed
- Conditions
- Vulvar Intraepithelial Neoplasia (VIN), vulvar dysplasiaCancerPrecancerous condition of the female genitalia
- Registration Number
- ISRCTN11290871
- Lead Sponsor
- Erasmus Medical Center (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
1. Histologically proven, multifocal VIN stage two or three without invasion
2. Age of 18 and older
3. Reliable method of contraception throughout the study
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method