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
Scientific
The Netherlands Cancer Institute
Department of Gynecology
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 (0)20 512 2975 |
|---|---|
| m.v.beurden@nki.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Imiquimod |
| Primary outcome measure | 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 study start date | 26/04/2001 |
| Completion date | 28/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 52 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/04/2001 |
| Date of final enrolment | 28/07/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands
1066 CX
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
