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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
ISRCTN ISRCTN11290871
DOI 10.1186/ISRCTN11290871
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis Imiquimod, an immunomodulator, has been shown safe and effective in the treatment of external genital warts caused by low risk human papillomavirus (HPV). Therefore, it is hypothesised that this topical treatment may also be effective against different HPV types, and thus encourage regression of dysplastic vulvar lesions caused by high risk HPV.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Vulvar Intraepithelial Neoplasia (VIN), vulvar dysplasia
Participants - 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
Participants - 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
Anticipated start date 26/04/2001
Anticipated end date 28/07/2005
Status of trial Completed
Patient information material
Target number of participants 52
Interventions After qualifying for study participation patients are randomly assigned to receive either 250 mg of imiquimod 5% cream (Aldara, 3M Pharmaceuticals, St Paul, MN, USA) or 250 mg of placebo cream.

Dosing will take place twice a week in the evening for a period of 16 weeks. A clinical assessment will take place every four weeks during treatment, and four weeks after final treatment. To investigate long-term effects and to exclude recurrence of VIN final assessments will take place after seven and 12 months.

A formalin fixed biopsy is taken for histological verification of VIN two/three within three months before the start of the study, together with a second biopsy from the same lesion frozen in liquid nitrogen for HPV deoxyribonucleic acid (DNA) testing. At 20 weeks a post-treatment biopsy is taken at exactly the same spot as the first biopsy to evaluate the histological effect, and again a frozen sample is taken for detection of HPV DNA. If a recurrence is suspected at 12 months a biopsy is taken again. In case of persistent or residual lesions after one year, the patient is offered treatment with imiquimod.
Primary outcome measure(s) Reduction in lesion size
Secondary outcome measure(s) 1. Histological regression
2. Clearance of HPV
3. Relief of clinical symptoms
4. Improvement of quality of life
Sources of funding 1. Erasmus Medical Center (The Netherlands) - Department of Obstetrics and Gynaecology
2. 3M Pharmaceuticals (USA)
3. Academic Medical Center (AMC) (The Netherlands) - Department of Obstetrics and Gynecology
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18385498
Contact name Dr  M  van Beurden
  Address The Netherlands Cancer Institute
Department of Gynecology
Plesmanlaan 121
  City/town Amsterdam
  Zip/Postcode 1066 CX
  Country Netherlands
  Tel +31 (0)20 512 2975
  Fax +31 (0)20 5122554
  Email m.v.beurden@nki.nl
Sponsor Erasmus Medical Center (The Netherlands)
  Address Department of Obstetrics and Gynecology
Dr. Molewaterplein 60
  City/town Rotterdam
  Zip/Postcode 3015 GJ
  Country Netherlands
Date applied 11/10/2006
Last edited 15/04/2008
Date ISRCTN assigned 11/10/2006
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