Chinese Journal of Dermatology ›› 2007, Vol. 40 ›› Issue (2): 67-70.

• Original articles •     Next Articles

Topical 5-aminolevulinic acid photodynamic therapy for the treatment of condyloma acuminatum:a multicenter,randomized,CO2 laser-controlled trial

TU Ping1, ZHENG He-yi2, GU Heng3, XU Jin-hua4, WANG Xiu-li5, CHEN Wei1, LI Jun2, CHEN Kun3, LU Xiao-nian4, WANG Hong-wei5, ZHU Xue-jun1   

  1. Department of Dermatology, Peking University First Hospital, Beijing 100034, China
  • Received:2006-04-12 Online:2007-02-15 Published:2007-02-15

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Abstract: Objective To evaluate the safety and efficacy of topical 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in the treatment of condyloma acuminatum.Methods This multicenter,randomized,open,parallel,CO2 laser-controlled clinical trial was conducted at 5 research sites in China.Patients with condyloma acuminatum were randomly assigned to the ALA-PDT group or the CO2 laser (control) group in an allocation ratio of 3:1.The treatment was repeated weekly if necessary,but no more than 3 times.The primary efficacy endpoint was the wart clearance rate 1 week after the last treatment.The recurrence rate was evaluated at weeks 4,8,and 12 after the treatment ended.The laboratory examinations were performed before and at the end of the treatment.Results A total of 453 patients with condyloma acuminatum were enrolled in the clinical trial.Of these,442 (97.57%) patients completed the trial (331 in the ALA-PDT group,and 111 in the control group).At 1 week after the last treatment,98.42% and 100% of the base line warts were eliminated in the ALA-PDT group and the control group,respectively (P>0.05).The clearance rate of condylomata acuminata at male urethral orifice was 99.43% in the ALA-PDT group and 100% in the control group (P>0.05).The overall recurrence rate calculated for the whole follow-up period was significantly lower in the ALA-PDT group than in the control group (10.77% vs 33.33%,P<0.0001),and the recurrence of condyloma acuminatum at male urethra orifice was also significantly decreased in the ALA-PDT group than in the control group (10.53% vs 36.36%,P<0.0001).There was no systemic adverse event in either group.The incidence of local adverse events was significantly lower in the ALA-PDT group than in the control group (7.67% vs.53.57%,P<0.0001).The main adverse event in the ALA-PDT group was mild erosion,whereas the adverse events in the control group were more common and severe,including pain,ulcer,and even scarring (n=14).Conclusions The results confirm that topical ALA-PDT is a safe and effective treatment with low recurrence rate for condyloma acuminatum,especially for this condition at urethral orifice.

Key words: Condylomata acuminata, Aminolevulinic acid, Photochemotherapy, Randomized controlled trials