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

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 (CO2) laser may enhance efficacy. OBJECTIVES CO2 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 CO2 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 CO2 laser vaporization, followed by illumination with red light (600‐740 nm, 100 mW/cm2, 100 J/cm2). 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 CO2 laser ablation was well tolerated, but no significant difference with regard to recurrence rate was observed from CO2 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.