Academic Journal
A randomized, intraindividual, non-inferiority, Phase III study comparing daylight photodynamic therapy with BF-200 ALA gel and MAL cream for the treatment of actinic keratosis.
| العنوان: | A randomized, intraindividual, non-inferiority, Phase III study comparing daylight photodynamic therapy with BF-200 ALA gel and MAL cream for the treatment of actinic keratosis. |
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| المؤلفون: | Dirschka, T, Ekanayake-Bohlig, S, Dominicus, R, Aschoff, R, Herrera-Ceballos, E, Botella-Estrada, R, Hunfeld, A, Kremser, M, Schmitz, B, Lübbert, H, Puig, S |
| سنة النشر: | 2018 |
| المجموعة: | Sistema Sanitario Público de Andalucía (SSPA): Repositorio |
| مصطلحات موضوعية: | Administration, Cutaneous, Aged, Aminolevulinic Acid, Female, Gels, Germany, Humans, Keratosis, Actinic, Male, Photochemotherapy, Photosensitizing Agents, Prognosis, Severity of Illness Index, Skin Cream, Spain, Statistics, Nonparametric, Treatment Outcome |
| الوصف: | The most effective treatment modality for actinic keratosis (AK) is photodynamic therapy (PDT). Major obstacles of PDT are the need of a special illumination device and pain accompanying the illumination. These issues may be overcome by replacing an artificial high-power light source with natural daylight for more extended illumination at lower light doses. To determine whether BF-200 ALA (a nanoemulsion gel containing 7.8% 5-aminolaevulinic acid) is non-inferior to MAL (a cream containing 16% methyl-aminolaevulinate) in the treatment of mild-to-moderate AK with daylight PDT (dPDT). Non-inferiority of the primary efficacy variable (total lesion clearance rate per patient's side 12 weeks after PDT) is established if the mean response for BF-200 ALA is no worse than for MAL, within a statistical margin of Δ = -12.5%. The study was performed as an intraindividual comparison with 52 patients in seven centres in Germany and Spain. Each patient received one dPDT. Results include clinical endpoints as well as 1-year follow-up results. Twelve weeks after a single dPDT, 79.8% of the AK lesions treated with BF-200 ALA gel and 76.5% of the lesions treated with MAL cream were completely cleared. The median of differences was 0.0 with a one-sided 97.5% CI of 0.0, establishing non-inferiority (P Daylight PDT of AK with BF-200 ALA is well-tolerated and non-inferior to MAL/dPDT. The study demonstrates a trend towards higher efficacies after 3 months and significantly lower recurrence rates after 1 year follow-up. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1468-3083 |
| Relation: | http://hdl.handle.net/10668/12724; PMC6585804; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585804/pdf |
| DOI: | 10.1111/jdv.15185 |
| الاتاحة: | http://hdl.handle.net/10668/12724 https://doi.org/10.1111/jdv.15185 https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/jdv.15185 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585804/pdf |
| Rights: | Attribution-NonCommercial-NoDerivatives 4.0 International ; http://creativecommons.org/licenses/by-nc-nd/4.0/ ; open access |
| رقم الانضمام: | edsbas.5672A6A7 |
| قاعدة البيانات: | BASE |
| تدمد: | 14683083 |
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| DOI: | 10.1111/jdv.15185 |