A comparison of aminolevulinic acid topical solution and blue light, aminolevulinic acid topical solution and a laser light source or topical 5-fluorouracil in broad area treatment of actinic keratoses of the face and scalp

Abstract

Background: Topical 20% aminolevulinic acid HCL (ALA) in conjunction with non-coherent blue light has been approved and marketed as a lesion-specific treatment for actinic keratoses. Since its introduction, the use of broad area photodynamic therapy (PDT), where entire affected areas as opposed to individual lesions are treated, has gained in popularity. Prior to the use of such broad area PDT, the standard of care for treating large areas of actinic keratoses has been topical 5-fluorouracil. Additionally, various light sources have been used and reported to be valuable in activating the sensitized tissue during PDT. The objective of this study is to compare the efficacy and tolerability of broad area PDT therapy with two different light sources as well as treatment with topical 5-fluoruracil. Methods: 36 patients with at least 4 actinic keratoses of the face and/or scalp were randomized to receive one of three treatments: topical ALA followed by non-coherent blue light activation, topical ALA followed by activation with a variable pulse duration dye laser or topical 5-fluorouracil. Response was evaluated by grading of target AK lesions for efficacy and evaluation of signs of inflammation (erythema, swelling, crusting etc). Patients selected for PDT therapy received up to two treatments, 30 days apart, depending upon their response. Patents selected for topical 5-FU therapy were to apply the medication for 28 days. Results: Differences in proportions of patients treated with total lesion clearing will be compared along with proportions sustaining less than complete clearing for patients treated with ALA PDT with non-coherent blue light, ALA PDT with laser light and with topical 5-fluorouracil. Similarly, proportions of patients with significant signs of irritation (erythema, crusting and pain) will be compared between each modality