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).