The role of the 595-nm pulsed dye laser in treating superficial basal cell carcinoma: outcome of a double-blind randomized placebo-controlled trial.

BACKGROUND: Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas (BCCs). However, robust supporting evidence is lacking due to inconsistent design of available studies.

OBJECTIVES: To evaluate PDL efficacy and safety in treating superficial BCC (sBCC) at low-risk anatomical sites in an evidence-based study setting.

MATERIALS AND METHODS: Thirty-nine patients (27 men and 12 women, 75·9 ± 10 years) with a total of 100 sBCCs were randomized to receive PDL treatment (wavelength 595 nm; fluence 8 J cm(-2) ; pulse duration 0·5 ms; spot size 10 mm) or sham treatment. The primary endpoint was complete clinical and histological remission of the tumour at 6-month follow-up; the secondary endpoints were the evaluation of side-effects and pain as well as patient satisfaction.

RESULTS: The primary endpoint showed significant superiority of the laser group to the sham group (P < 0·0001). Complete remission was achieved in 44 of 56 cases (78·6%) in the laser and in two of 44 cases (4·5%) in the sham treatment arm. The main adverse events in the laser group were crusts, hyper- and hypopigmentation. An average of 72% of patients stated at the individual sessions that they were 'satisfied' with the laser treatment, whereas 25% were 'very satisfied'.

CONCLUSIONS: PDL is an effective and safe method for treating sBCC. However, the occurrence of persistent dyspigmentation still limits the potential for excellent cosmetic outcomes.