Adjuvant Photodynamic Therapy Does Not Prevent Recurrence of Condylomata Acuminata After Carbon Dioxide Laser Ablation-A Phase III, Prospective, Randomized, Bicentric, Double-Blind Study

作者：Szeimies Rolf Markus^*; Schleyer Verena; Moll Ingrid; Stocker Marcus; Landthaler Michael; Karrer Sigrid

来源：Dermatologic Surgery, 2009, 35(5): 757-764.

DOI：10.1111/j.1524-4725.2009.01125.x

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.
CO(2) laser ablation was followed by ALA-PDT in a phase III prospective randomized bicenter double-blind study to prevent recurrence of CA.
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)).
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.
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.
This study was funded by Medac GmbH, Wedel, Germany. The investigating authors received payments for this research project. Marcus Stocker is an employee of Medac.

• 出版日期2009-5