Sinecatechins 10% Ointment: A Green Tea Extract for the Treatment of External Genital Warts

Aditya K. Gupta, MD, PhD, FAAD, FRCPC; Deanne Daigle, MSc

Disclosures

Skin Therapy Letter. 2015;20(1) 

In This Article

Clinical Efficacy

Gross et al. conducted a Phase II/III, randomized, double-blind trial to assess the efficacy and safety of two formulations of sinecatechins ointment for the treatment of EGW.[13] Two hundred and forty-two participants (125 males, 117 females) with 2–30 warts (wart area of 12–600 mm2) were randomized to receive either sinecatechins 15% ointment, sinecatechins 10% cream, or placebo (two placebo arms pooled for analyses). Participants were instructed to apply their respective treatments three times a day for 12 weeks and those who achieved complete clearance at the end of 12 weeks were followed for an additional 12 weeks. Rates of complete clearance of baseline warts and of all warts (baseline and new) as well as recurrence rates for sinecatechins 10% cream and vehicle are displayed in Table 1. No significant differences between sinecatechins 10% cream and placebo groups were found.

The efficacy of sinecatechins 10% ointment in the treatment of EGWs was further assessed in two identically-designed, randomized, double-blind, Phase III trials,[14,15] the pooled results were also reported.[16] A total of 1,005 participants (535 men and 470 women) with 2–30 EGWs and a lesion area of 12–600 mm[2] were allocated in a 2:2:1 ratio to receive sinecatechins 15% ointment, sinecatechins 10% ointment or vehicle. Treatment was applied at 8-hour intervals three times a day for 16 weeks or until complete resolution of all baseline warts was observed. Complete responders were followed for an additional 12 weeks. Phase III trial results are displayed in Table 1. Rates of complete clearance of all warts in both sinecatechins ointment groups were significantly superior to vehicle (Ps<0.001). Time to complete clearance was also shorter for participants treated with sinecatechins 15% and 10% ointment than those treated with vehicle (P<0.01). Median time to complete wart clearance in the two trials was 16 weeks and 10 weeks in the sinecatechins 15% and 10% ointment groups, respectively. In all studies, recurrence rates were low and complete clearance rates were higher in women than in men.

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