Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical methylaminolevulinic acid: results of a randomized controlled trial

Summary

Background

Basal cell carcinoma (BCC) is the most common type of skin cancer with growing incidence rates. Photodynamic therapy (PDT) is a frequently used treatment, especially for superficial BCC (sBCC). Two topical photosensitizing agents are currently used to treat sBCC: 5-aminolevulinic acid (ALA) and its methyl-ester (MAL). Previous research showed a high efficacy of ALA-PDT using a 2-fold fractionated illumination scheme in which two light fractions of 20 and 80 J/cm2 are delivered, four and six hours after ALA application.

Objectives

To evaluate whether this 2-fold ALA-PDT is superior to conventional MAL-PDT for sBCC.

Methods

We performed a single blind, randomized multi-centre trial in the Netherlands.

Results

162 patients were randomized to either conventional MAL-PDT or 2-fold ALA-PDT. After 12 months a total of 6 treatment failures occurred after ALA-PDT and 13 after MAL-PDT. The 12 months cumulative probability of remaining free from treatment failure was 92.3% (95% CI [83.7-96.5]) and 83.4 (95% CI [73.1-90.0]), respectively (p=0.091).

Conclusions

The 2-fold ALA-PDT scheme resulted in fewer recurrences, although the difference between both treatment groups was not statistically significant. On the contrary, it resulted in higher pain scores and more post-treatment side-effects compared to MAL-PDT.

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