Condition category
Cancer
Date applied
11/10/2006
Date assigned
11/10/2006
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes