Baseline characteristic of the study cohort
A summary of patient characteristics in the cohort is outlined in Table
1. A total of 26 patients with histological confirmation of uVIN were
recruited into our study, and an equal number of patients were
randomised into VeregenĀ® (n=13) or placebo (n=13) treatment arms. The
mean age of our cohort was 51 years old; 25 (96.2%) patients recruited
presented with recurrent disease, and only 1 (3.8%) patient had primary
uVIN. Our patient cohort has a long-standing history of uVIN with a mean
presentation of 10.70 years (1.04, 30.38 years); these patients also
suffered from long-term symptoms with a mean duration of 22.78 months
prior to randomisation (Table 1). Over half of the patients (53.8%,
n=14) presented with a unifocal uVIN lesion, with the remainder (n=12,
46.2%) presenting with multifocal lesions; two patients presented with
five separate lesions. The baseline means cumulative lesion size was
3.46cm (1.00, 12.50cm). The majority of our patients were either current
cigarette smokers (57.7%, n=15) or ex-smoker (34.6%, n=9); only two
patients have never smoked.
The majority of patients (n=25, 80.8%) received either previous
medical, surgical or both modalities of treatment, with only three
patients receiving no prior treatment before being randomised into
accepting VeregenĀ®. Data for two patients were unavailable. Most of
these patients (n=20) had undergone surgical excision, while eight
patients were previously treated with Imiquimod. In addition, five
patients had also received laser ablative treatment prior to
randomisation. A total of nine patients had multimodality treatments,
six patients receiving two different treatment modalities, and three
patients receiving three different treatment modalities. Only one
patient did not have surgery but received ablative therapy and Imiquimod
on separate occasions (Table 1).