T Helmerhorst

Dr T Helmerhorst, Erasmus University Medical Center, Rotterdam, The Netherlands; t.helmerhorst@erasmusmc.nl

STUDY DESIGN

Design:

randomised placebo controlled trial.

Allocation:

concealed.*

Blinding:

blinded (patients, clinicians, outcome assessors, {data collectors, and safety committee}†).*

STUDY QUESTION

Setting:

2 academic medical centres in the Netherlands.

Patients:

52 women ⩾18 years of age (range 22–71 y) who had multifocal grade 2 or 3 vulvar intraepithelial neoplasia without microinvasion and used contraceptives if they were premenopausal and sexually active. Exclusion criteria included cancer or inflammatory dermatosis of the vulva, pregnancy, immunodeficiency, any treatment for vulvar intraepithelial neoplasia or warts within the previous month, and hypersensitivity to the study …