Phototoxic reactions in healthy volunteers following photodynamic therapy with methylaminolevulinate cream or with cream containing 5-aminolevulinic acid: a phase II, randomized study

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Abstract:

Background:

Photodynamic therapy (PDT) is the selective destruction of abnormal cells through activation of a photosensitizer in the presence of oxygen. Local phototoxic reactions and pain are the most common limiting side effects. Purpose:

The primary objective was to compare the local phototoxic response following PDT with methylaminolevulinate (MAL) and 5-aminolevulinic acid (ALA). The secondary objectives were to compare the two treatments regarding pain, detection of substance P, change in fluorescence intensity from before to 5 h after cream application and adverse events not related to local phototoxicity. Methods:

Thirty-four healthy volunteers were treated by PDT using MAL 160 mg/g cream and ALA cream 20% randomly assigned to treatment areas on the inside of each upper arm. A composite score of local phototoxic events (erythema, edema, hyperpigmentation) was calculated. Results:

The area under the curve (AUC) analysis of composite scores showed a significantly higher AUC for ALA-PDT (P≤0.0001). ALA- and MAL-PDT showed equivalent local side-effect frequencies, except for a higher frequency of hyperpigmentation after 28 d using ALA-PDT (P=0.006). Conclusion:

MAL- and ALA-PDT are nearly equivalent regarding individual side-effect frequencies, but MAL-PDT has a more favorable phototoxicity pattern as seen by AUC analysis and the lower frequency of long-lasting hyperpigmentation.

Keywords: aminolevulinic acid; methylaminolevulinate; pain; photodynamic therapy; phototoxicity

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1600-0781.2009.00455.x

Affiliations: 1: Department of Dermatology, Regensburg University Hospital, Regensburg, Germany, and 2: BIOCAM GmbH, Regensburg, Germany

Publication date: October 1, 2009

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