HPV-induced condylomata acuminata treated by Photodynamic Therapy in comparison with trichloroacetic acid: A randomized clinical trial

Objectives: This is a randomized controlled clinical trial comparing Photodynamic Therapy (PDT) and the application of trichloracetic acid (TAA) in the treatment of HPV condyloma in the perianal and vulva regions. Design, Randomised controlled, open label, trial. They were allocated to each treatment following randomization by a computer program. Setting: Women Health Ambulatory in São Carlos city, São Paulo State in the Brazil. Participants: 36 patients evaluated. 31 patients fulfilled the study requirements. Intervention: Photodynamic Therapy (PDT) versus trichloracetic acid (TAA). The PDT protocol used the prodrug methyl aminolevulinate incubated for 3 hours and irradiation at 630 nm (100 J/cm²). In the treatment using TAA, warts received a small amount of acid using a cotton swab. Both treatments were repeated weekly until the lesions disappeared completely or until 10 sessions were completed. Main outcome measure: Clinical analysis. Follow-up between 12 and 30 months after the complete treatment. Results: A total of 16 patients were treated with PDT and 15 patients with TAA. A complete response rate of 60% for TAA and 63% for PDT, with a recurrence rate of 33% for TAA and 0% for PDT. Conclusion: PDT appears not only to treat lesions due to physical destruction of condyloma and subclinical lesions, but also to modulate the immune system and/or also to decrease the local viral load, suggesting a lower recurrence compared to the TAA group. Keywords: Clinical Trial; Condylomata acuminate; Genital warts; Human Papillomavirus; Methyl aminulevulinate; Photodynamic Therapy; Trichloroacetic acid.