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 (CO(2)) laser may enhance efficacy.


OBJECTIVE
CO(2) laser ablation was followed by ALA-PDT in a phase III prospective randomized bicenter double-blind study to prevent recurrence of CA.


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.


CONCLUSIONS
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.
Szeimies
Rolf-Markus
RM
Department of Dermatology, Regensburg University Hospital, Germany. Rolf-Markus.Szeimies@klinik.uni-regensburg.de
Schleyer
Verena
V
Moll
Ingrid
I
Stocker
Marcus
M
Landthaler
Michael
M
Karrer
Sigrid
S
D000287:Administration, Topical; D000328:Adult; D003218:Condylomata Acuminata / Q000473:pathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005831:Genital Diseases, Female / Q000473:pathology / Q000628:therapy*; D005832:Genital Diseases, Male / Q000473:pathology / Q000628:therapy*; D052163:Human papillomavirus 6 / Q000302:isolation & purification; D006801:Humans; D053685:Laser Therapy / Q000379:methods*; D054020:Lasers, Gas / Q000627:therapeutic use*; D008297:Male; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D055502:Secondary Prevention; D016896:Treatment Outcome
D017319:Photosensitizing Agents