Contact information
Type
Scientific
Primary contact
Dr M van Beurden
ORCID ID
Contact details
The Netherlands Cancer Institute
Department of Gynecology
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
+31 (0)20 512 2975
m.v.beurden@nki.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Vulvar Intraepithelial Neoplasia (VIN), vulvar dysplasia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Imiquimod
Primary outcome measures
Reduction in lesion size
Secondary outcome measures
1. Histological regression
2. Clearance of HPV
3. Relief of clinical symptoms
4. Improvement of quality of life
Overall trial start date
26/04/2001
Overall trial end date
28/07/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
52
Participant 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
Recruitment start date
26/04/2001
Recruitment end date
28/07/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Center (The Netherlands) - Department of Obstetrics and Gynaecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
3M Pharmaceuticals (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Center (AMC) (The Netherlands) - Department of Obstetrics and Gynecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18385498
Publication citations
-
Results
van Seters M, van Beurden M, ten Kate FJ, Beckmann I, Ewing PC, Eijkemans MJ, Kagie MJ, Meijer CJ, Aaronson NK, Kleinjan A, Heijmans-Antonissen C, Zijlstra FJ, Burger MP, Helmerhorst TJ, Treatment of vulvar intraepithelial neoplasia with topical imiquimod., N. Engl. J. Med., 2008, 358, 14, 1465-1473, doi: 10.1056/NEJMoa072685.