Main findings
Our study demonstrates that Veregen®, a topical EGCG ointment, is not only safe but potentially effective in the treatment of uVIN. All patients in the Veregen® treatment arm showed at least a partial clinical response with only 2 patients showing disease progression and recurrence, respectively, at 52 weeks follow up. Results from DLQI and McGills pain scores suggest a trend towards symptom improvements following Veregen® treatment when compare to baseline and placebo, thus, implicating that topical application of EGCG treatment offers symptoms relieve in these patients. Although approximately 30% of patients in the Veregen® group did not adhere to treatment protocol and had to reduce treatment dose or prematurely stop treatment, the side effects profiles were reasonably good with the majority of patients experiencing grade 1 or 2 toxicity in the form of localised irritation. When compared to baseline or pre-treatment, many patients already had underlying symptoms of local irritation, and Veregen® treatment per se did not worsen their symptoms substantially. Moreover, all the adverse effects reported by patients were fully reversible upon stopping Veregen® treatment.