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 https://doi.org/10.1186/ISRCTN11290871
Secondary identifying numbers N/A
Submission date
11/10/2006
Registration date
11/10/2006
Last edited
15/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M van Beurden
Scientific

The Netherlands Cancer Institute
Department of Gynecology
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Phone +31 (0)20 512 2975
Email m.v.beurden@nki.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesImiquimod, 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedVulvar Intraepithelial Neoplasia (VIN), vulvar dysplasia
InterventionAfter 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Imiquimod
Primary outcome measureReduction in lesion size
Secondary outcome measures1. Histological regression
2. Clearance of HPV
3. Relief of clinical symptoms
4. Improvement of quality of life
Overall study start date26/04/2001
Completion date28/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants52
Key inclusion criteria1. Histologically proven, multifocal VIN stage two or three without invasion
2. Age of 18 and older
3. Reliable method of contraception throughout the study
Key exclusion criteria1. 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
Date of first enrolment26/04/2001
Date of final enrolment28/07/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Center (The Netherlands) - Department of Obstetrics and Gynaecology

No information available

3M Pharmaceuticals (USA)

No information available

Academic Medical Center (AMC) (The Netherlands) - Department of Obstetrics and Gynecology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 03/04/2008 Yes No