Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2019
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.
Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed.
- Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Trial
- Expert consensus-based recommendations on the use of photodynamic therapy in actinic keratosis patients.JAAD international · 2025Article
- Daylight Photodynamic Therapy for Actinic Keratosis and Field Cancerization: A Narrative Review.Cancers · 2025Review
- Daylight Photodynamic Therapy: At-Home Delivery.Journal of clinical medicine · 2024Article
- Vascular Characteristics of Treatment-resistant and -responsive Actinic Keratosis Identified with Dynamic Optical Coherence Tomography.Acta dermato-venereologica · 2024Article
- Field Cancerization Therapies for the Management of Actinic Keratosis: An Updated Review.American journal of clinical dermatology · 2024Review
- The use of photodynamic therapy in medical practice.Frontiers in oncology · 2024Review
- Photodynamic Therapy for Field Cancerization in the Skin: Where Do We Stand?Dermatology practical & conceptual · 2023Review
- Pharmacological Agents Used in the Prevention and Treatment of Actinic Keratosis: A Review.International journal of molecular sciences · 2023Review
- Advances in Photodynamic Therapy for the Treatment of Actinic Keratosis and Nonmelanoma Skin Cancer: A Narrative Review.Dermatology and therapy · 2023Review
- Global Trends and Research Progress of Photodynamic Therapy in Skin Cancer: A Bibliometric Analysis and Literature Review.Clinical, cosmetic and investigational dermatology · 2023Review
- Review
- Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF-200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials.Clinical pharmacology in drug development · 2022Article
- Approaches to Field Therapy for Actinic Keratoses: Relating Clinical Trial Results to Real-world Practice-A Commentary.The Journal of clinical and aesthetic dermatology · 2022Article
- Topical Photodynamic Therapy with Different Forms of 5-Aminolevulinic Acid in the Treatment of Actinic Keratosis.Pharmaceutics · 2022Article
- Topical Pharmacotherapy for Actinic Keratoses in Older Adults.Drugs & aging · 2022Review
- Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel and Red Light for the Treatment of Actinic Keratosis, Nonmelanoma Skin Cancers, and Acne: Current Evidence and Best Practices.The Journal of clinical and aesthetic dermatology · 2021Review
- The application of physical pretreatment in photodynamic therapy for skin diseases.Lasers in medical science · 2021Review
- Micro- and Nano-Based Transdermal Delivery Systems of Photosensitizing Drugs for the Treatment of Cutaneous Malignancies.Pharmaceuticals (Basel, Switzerland) · 2021Review
- [Decision criteria and patient characteristics for patient-oriented treatment of field cancerization : Standardized algorithm for personalized treatment concepts].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundThe 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.
objectiveTo 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%.
methodsThe 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.
resultsTwelve 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 < 0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 1 year after the treatment were 19.9% for lesions treated with BF-200 ALA and 31.6% for lesions treated with MAL. Adverse reactions including pain were mostly mild and transient and identical to those previously described for dPDT.
conclusionDaylight 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.
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