COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Single treatment of low-risk basal cell carcinomas with pulsed dye laser-mediated photodynamic therapy (PDL-PDT) compared with photodynamic therapy (PDT): A controlled, investigator-blinded, intra-individual prospective study.

BACKGROUND AND OBJECTIVE: To compare a single treatment of PDL-PDT with PDT for BCCs in terms of efficacy, aesthetic outcome, and pain in patients with multiple BCCs.

STUDY DESIGN/MATERIALS AND METHODS: A prospective, controlled, intra-individual, investigator-blinded study was conducted on 15 patients with 62 BCCs. The BCCs on an individual patient were divided into two similarly-sized groups, and treated with PDT (630nm LED light source, fluence rate=30mW/cm2 , total dose of 150J/cm2 ) and 585 nm-PDL-PDT (spot size=7mm, fluence=10J/cm2 , pulse duration=10ms, 10% overlap, three passes, and cooling). Primary outcomes were complete BCC regression at months 3 and 12. Secondary outcomes were pain immediately after treatment, and aesthetic outcome evaluated by a blinded investigator.

RESULTS: No significant difference was found in the therapeutic effect between the two treatments (P=0.285). Complete regression of BCCs at 3-months follow-up occurred in 79% of the PDT treated area and 74% of the PDL-PDT area. At month 12, complete regression using PDT was 75% (95% confidence interval (CI) 0.55-0.89) compared to 59% (95% CI 0.41-0.75) for the PDL-PDT treated areas. Both treatments had low mean pain scores: 1.7 for PDT and 2.6 for PDL-PDT (P=0.049) and the aesthetic appearance was similar (P=0.763).

CONCLUSION: A single treatment with three passes of PDL-PDT is effective in clearing BCCs, but the recurrence rate is higher than in case of conventional PDT. PDL-PDT is associated with low treatment related pain, has similar cosmetic advantages as PDT but it requires less treatment time.

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