Abstract
Conventional photodynamic therapy (cPDT) using red light is considered one of the most effective therapy option for the treatment of actinic keratosis (AK). The main disadvantage of cPDT is the pain experienced by the patients during illumination. Daylight PDT (dPDT) represents an effective and painless alternative. It can be speculated that a combination of both regimes combines their benefits. To compare the combination of cPDT and dPDT (combPDT) to dPDT alone in terms of effectiveness and safety. The study was developed as a single-centre, intraindividual, retrospective study. Each patient received one dPDT and a combPDT session with BF-200 ALA. Primary effectiveness endpoints included the reduction in the number of basal AK, percentage of patients with complete response (CR) and partial response (PR). Safety parameters evaluated were local skin response (LSR) and visual analogue scale (VAS). A total of 19 patients with 264 AK were evaluated 12 weeks after both PDT modalities. The area treated with combPDT showed a reduction in the number of AK lesions (82.7%) when compared to the dPDT-treated area (56.8%). Higher rates of CR (31.6% vs 15.8) and PR (63.2% vs 26.3%) were achieved in combPDT fields. Areas treated with combPDT showed enhanced local skin reactions (LSR) in comparison with dPDT-treated areas (6.4 vs.4.4, respectively). In combPDT-treated patients a moderate increase of the pain during illumination was observed when compared to dPDT (VAS: 3.4 vs 0.6). This study reports the first data set on the benefit of a direct combination of daylight and subsequent conventional red light illumination (combPDT) with BF-200 ALA. The combination approach achieved a significant increase in clearance rates of AK lesions, while pain was perceived as mild to moderate during red light illumination.
References
Patel G, Armstrong AW, Eisen DB (2014) Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systematic review and meta-analysis. JAMA Dermatol 150:1281–1288
Vegter S, Tolley K (2014) A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe. PLoS ONE 9(6):e96829
Wiegell SR, Haedersdal M, Philipsen PA, Eriksen P, Enk CD, Wulf HC (2008) Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study. Br J Dermatol 158:740–746
Neittaanmaki-Perttu N, Karppinen TT, Gronroos M, Tani TT, Polonen I, Snellman E (2014) Daylight photodynamic therapy for actinic keratoses: A randomized double-blinded non-sponsored prospective study comparing BF-200 aminolevulinic acid with methyl-5-aminolaevulinate. Br J Dermatol 171:1172–1180
Zhao W, Guan M, Nong X, Li Q, Chen Z (2019) The safety and efficacy of daylight photodynamic therapy in the treatment of actinic keratoses: a systematic review and meta-analysis. Int J Dermatol 58:159–166
Mei X, Wang L, Zhang R, Zhong S (2019) Daylight versus conventional photodynamic therapy for the treatment of actinic keratosis: a meta-analysis of randomized controlled trials. Photodiagnosis Photodyn Ther 25:23–28
Olsen EA, Abernethy ML, Kulp-Shorten C et al (1991) A double-blind, vehiclecontrolled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol 24:738–743
Gilaberte Y, Aguilar M, Almagro M et al (2015) Spanish-Portuguese consensus statement on use of daylight-mediated photodynamic therapy with methyl aminolevulinate in the treatment of actinic keratosis. Actas Dermosifiliogr 106:623–631
Vignion-Dewalle AS, Baert G, Thecua E et al (2018) Comparison of 10 efficient protocols for photodynamic therapy of actinic keratosis: How relevant are effective light dose and local damage in predicting the complete response rate at 3 months? Lasers Surg Med 50:576–589
Dirschka T, Radny P, Dominicus R et al (2012) Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Br J Dermatol 166:137–146
Reinhold U, Dirschka T, Ostendorf R et al (2016) A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz((R))) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED((R)) lamp. Br J Dermatol 175:696–705
Szeimies RM, Radny P, Sebastian M et al (2010) Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Br J Dermatol 163:386–394
Skov T, Stockfleth E, Szeimies RM, Berman B (2018) Efficacy Endpoints in Clinical Trials in Actinic Keratosis. Dermatol Ther (Heidelb) 8:425–433
Reinhold U (2017) A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis. Future Oncol 13:2413–2428
Castano AP, Mroz P, Hamblin MR (2006) Photodynamic therapy and anti-tumour immunity. Nat Rev Cancer 6:535–545
Wiegell SR, Wulf HC, Szeimies RM et al (2012) Daylight photodynamic therapy for actinic keratosis: an international consensus: international society for photodynamic therapy in dermatology. J Eur Acad Dermatol Venereol 26:673–679
Yu X, Zheng H, Chan MTV, Wu WKK (2018) Immune consequences induced by photodynamic therapy in non-melanoma skin cancers: a review. Environ Sci Pollut Res Int 25:20569–20574
Serra-Guillen C, Nagore E, Llombart B et al (2018) A 12-day course of imiquimod 5% for the treatment of actinic keratosis: effectiveness and local reactions. Actas Dermosifiliogr 109:248–253
Funding
None.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
Dr. Salido-Vallejo has served as advisor for Almirall, Biofrontera and Leo Pharma and participated in clinical trials for Almirall and Leo Pharma. He has received speaker´s honoraria for Almirall, Biofrontera, Cantabria Labs, Galderma and MEDA. The rest of authors have no conflict of interest.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Salido-Vallejo, R., Jiménez-Nájar, F., Garnacho-Sucedo, G. et al. Combined daylight and conventional photodynamic therapy with 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) for actinic keratosis of the face and scalp: a new and efficient approach. Arch Dermatol Res 312, 675–680 (2020). https://doi.org/10.1007/s00403-019-02028-2
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00403-019-02028-2