Randomized, double-blind controlled clinical trial of Keyoudu Ointment vs placebo in treatment of condyloma acuminatum with syndrome of damp-toxin accumulation.

Objective To evaluate the efficacy and safety of relapse rate and anti-wart of Keyoudu Ointment in treatment of condyloma acuminatum (CA) with syndrome of damp-toxin accumulation.Methods A randomized,double-blind,parallel controlled,multi-center clinical study was conducted.All 454 cases of Full Analysis Set(FAS) were divided 340 cases into Keyoudu Ointment group(trial group)and 114 cases into placebo group(control group).All 429 cases of Per Protocol Set(PPS) were divided 323 cases and 106 cases into two groups respectively.The wart was coated with ointment 3 times a day for one treatment courses(3 weeks) and follow-up observation(3 months).The effective indexs were relapse rate and anti-wart efficacy of CA,but the safety indexs were laboratory indexs and adverse reactions. Results FAS analysis:The relapse rate of CA(17.65% vs 59.65%)and total markedly effective rate of anti-wart(20.00% vs 2.63%)in trial group were superior to those in control group(P0.05)respectively.PPS analysis:The relapse rate of CA(18.58% vs 64.15%) and total markedly effective rate of anti-wart(20.74% vs 2.83%) in trial group were superior to those in control group(P0.05).The incidence of adverse events showed no statistical differences between two groups(5.56% vs 6.58%,P=0.7871).Conclusion Keyoudu Ointment has a lower relapse rate and is security in clinical practice.