Objectives: To investigate the efficacy and safety of topical application of 5-aminolaevulinic acid (ALA) pho-todynamic therapy (PDT) for the treatment of condylomata acuminata (CA) in larger population. Methods: Patients with CA were given a treatment of ALA-PDT once a week for 3 weeks and followed up at 4, 8, 12 and 24 weeks after the treatment finished. Results: In 531 patients, a clearance rate was observed 95.27%. The rates rouse with PDT cycles. The clearance rate of three PDT cycles was

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... ignificant higher than one PDT cycles (P < 0.001) and two PDT cycles (P < 0.001). The clearance rate (88.73%) of small lesions (diameter small than 5mm) was significant higher than that (97.74%) of larger lesions (P < 0.001). The clearance rate varied with the location of the lesions. The clearance rate of urethral meatus was highest and that of perianal was lowest. Follow-up for patients with complete response lasted for 24 weeks. The recurrence rate was 5.65%, 11.30%, 15.07%, 15.44% and 16.20% after 1, 4, 8, 12 and 24 weeks. The recurrence rate varied with the location of the lesions. The recurrence rate of perianal was highest and that of labium was lowest. The side effects mainly included flare, pain, erosion, ulcer, and hyperpig-mentation. The adverse reaction rate was 7.72%, 8.10%, 2.26%, 0.94% and 0.19%. Sexual dysfunction and urethral malformations were not observed during the 24 weeds visit. Conclusion: Topical application of ALA-PDT is a simple and as effective therapy with a lower incidence of adverse effects in the treatment of condylomata acuminata.