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Evaluation of photodynamic therapy using topical aminolevulinic acid hydrochloride in the treatment of condylomata acuminata: a comparative, randomized clinical trial
Author(s) -
Liang Jun,
Lu Xiao Nian,
Tang Hui,
Zhang Zhen,
Fan Jing,
Xu Jin Hua
Publication year - 2009
Publication title -
photodermatology, photoimmunology and photomedicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.736
H-Index - 60
eISSN - 1600-0781
pISSN - 0905-4383
DOI - 10.1111/j.1600-0781.2009.00467.x
Subject(s) - photodynamic therapy , medicine , adverse effect , clinical endpoint , randomized controlled trial , clinical trial , clinical efficacy , surgery , urology , gastroenterology , anesthesia , chemistry , organic chemistry
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 was100% 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.