Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2009
Adjuvant photodynamic therapy does not prevent recurrence of condylomata acuminata after carbon dioxide laser ablation-A phase III, prospective, randomized, bicentric, double-blind study.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Szeimies Rolf-Markus, Schleyer Verena, Moll Ingrid, Stocker Marcus, Landthaler Michael, Karrer Sigrid
Аннотация
BACKGROUND: Recurrence after therapy for anogenital warts, or condylomata acuminata (CA), is common. Topical photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) is efficient in the treatment of CA, but one problem with PDT is the limited penetration depth of photosensitizer and light. Pre-PDT vaporization of CA using a carbon dioxide (CO(2)) laser may enhance efficacy.
OBJECTIVES: CO(2) laser ablation was followed by ALA-PDT in a phase III prospective randomized bicenter double-blind study to prevent recurrence of CA.
MATERIALS AND METHODS: One hundred seventy-five patients with CA received CO(2) laser vaporization plus adjuvant ALA-PDT (n=84) or adjuvant placebo-PDT (n=91). A 20% ALA or placebo ointment was applied to the CA area 4 to 6 hours before CO(2) laser vaporization, followed by illumination with red light (600-740 nm, 100 mW/cm(2), 100 J/cm(2)).
RESULTS: Cumulative recurrence rate 12 weeks after treatment was 50.0% in the ALA-PDT group, versus 52.7% in the placebo-PDT group (p=.72). No statistically significant difference between groups was detected with regard to recurrence rates up to 12 months after treatment. No major complications were observed.
CONCLUSION: Adjuvant ALA-PDT of CA after CO(2) laser ablation was well tolerated, but no significant difference with regard to recurrence rate was observed from CO(2) laser vaporization alone.
OBJECTIVES: CO(2) laser ablation was followed by ALA-PDT in a phase III prospective randomized bicenter double-blind study to prevent recurrence of CA.
MATERIALS AND METHODS: One hundred seventy-five patients with CA received CO(2) laser vaporization plus adjuvant ALA-PDT (n=84) or adjuvant placebo-PDT (n=91). A 20% ALA or placebo ointment was applied to the CA area 4 to 6 hours before CO(2) laser vaporization, followed by illumination with red light (600-740 nm, 100 mW/cm(2), 100 J/cm(2)).
RESULTS: Cumulative recurrence rate 12 weeks after treatment was 50.0% in the ALA-PDT group, versus 52.7% in the placebo-PDT group (p=.72). No statistically significant difference between groups was detected with regard to recurrence rates up to 12 months after treatment. No major complications were observed.
CONCLUSION: Adjuvant ALA-PDT of CA after CO(2) laser ablation was well tolerated, but no significant difference with regard to recurrence rate was observed from CO(2) laser vaporization alone.