Type of publication:
Randomised controlled trial
Yap, Jason; Slade, Daniel; Goddard, Harriet; Dawson, Christopher; Ganesan, Raji; Velangi, Shireen; *Sahu, Banchhita; Kaur, Baljit; Hughes, Ana; Luesley, David
BJOG : an international journal of obstetrics and gynaecology; Oct 2020 [epub ahead of print]
OBJECTIVETo compare the safety and efficacy of 10% sinecatechins (Veregen®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN).DESIGNA Phase II double-blind randomised control trial.SETTINGA tertiary gynaecological oncology referral center.POPULATIONAll women diagnosed with primary and recurrent uVIN.METHODSEligible patients were randomised 1:1 to receive either sinecatechins 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 MEASURESThe primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores.RESULTSThere was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n=5) or partial (n=8) CR, when best CR was evaluated. In placebo group, 3 patients had complete CR, 2 had partial CR, 6 had stable disease and 2 were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002). There was no difference in toxicity reported in both groups.CONCLUSIONAlthough we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study.
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