Abtsract
Objective To compare the safety and efficacy of Veregen®
ointment against placebo in the treatment of usual type vulvar
intraepithelial neoplasia (uVIN).
Design A Phase II randomised control trial.
Setting A tertiary gynaecological oncology referral center.
Population All women diagnosed with primary and recurrence
uVIN.
Methods Eligible patients were randomised to receive either
Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and
were followed up at 2, 4, 8, 16, 32 and 52 weeks.
Main outcome measures Outcome measures, recorded at 16 and 32
weeks, were histological (HR) and clinical (CR) response (as measured by
≥30% reduction in the sum of the longest diameter of all lesions when
compared to baseline), toxicity and changes in quality of life and pain
scores.
Results 26 patients were randomised and all 13 patients who
received Veregen® showed either complete (n=5) or partial (n=8) CR with
a trend towards an improvement in baseline symptoms. In placebo group, 3
patients had complete CR, 2 had partial CR and 6 had stable disease.
Patients in the Veregen® group showed a significant improvement in CR as
compared to the placebo group (P=0.0026). There was no evidence of
difference in HR and toxicity reported in both groups.
Conclusion Our study indicates that Veregen application is safe
and leads to at least a partial clinical resolution of uVIN lesions and
symptoms improvement, thus warranting a phase III multi-centre RCT.
Key words: vulvar intraepithelial neoplasia, epigallocatechin-3-gallate,
human papillomavirus, quality of life
Tweetable abstract A randomised control study indicating that
Veregen® ointment may be a novel treatment for uVIN.