Evaluation of photodynamic therapy using topical aminolevulinic acid hydrochloride in the treatment of condylomata acuminata: a comparative, randomized clinical trial.

OBJECTIVES: To determine the safety and efficacy of photodynamic therapy (PDT) with topical application of 20% wt/vol aminolevulinic acid hydrochloride (ALA) in the treatment of condylomata acuminata (CA).

STUDY DESIGN: Patients with CA were randomly allocated into the ALA-PDT group and the CO(2) laser 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 clinical response to therapy and adverse effects were recorded.

RESULTS: A total of 91 patients with CA were enrolled in the clinical trial. Of these 90 (98.9%) patients completed the trial (67 in the ALA-PDT group, and 23 in CO(2) laser group). By 1 week after the last treatment, the complete clearance rate was 95.93% in the ALA-PDT group and 100% in CO(2) laser group (P>0.05). The clearance rate of CA at male urethral orifice was 100% in the ALA-PDT group and 100% in the CO(2) laser group (P>0.05). The overall recurrence rate calculated by the end of the entire follow-up period was significantly lower in the ALA-PDT group than that in the CO(2) laser group (9.38% vs 17.39%, P<0.05). Moreover, there was no systemic adverse event in either group. The proportion of patients with adverse effects in the ALA-PDT group (8.82%) was also significantly lower than that in the CO(2) laser group (100%, P<0.05). The side-effects in patients treated with ALA-PDT mainly included mild burning and/or stinging restricted to the illuminated area.

CONCLUSION: The results confirmed that topical application of ALA-PDT is a simpler and as effective therapy with a lower incidence of adverse effects in the treatment of CA compared with conventional CO(2) laser therapy.