A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis
Abstract
BF-200 ALA is a combination of a nanoscale-lipid vesicle formulation and the prodrug 5-aminolevulinic acid (5-ALA). The nanoemulsion stabilizes the prodrug and enhances its penetration through the stratum corneum. It has shown excellent therapeutic results in both lesion and field-directed photodynamic therapy of actinic keratosis (AK). AK is an early form of epidermal neoplasia and a precursor of invasive cutaneous squamous cell carcinoma. It is characterized by the combination of visible neoplastic lesions and surrounding tissue also harboring tumorigenic UV-induced mutations: a concept called field cancerization. A selective, field-directed treatment is ideal to meet the requirements of field change. Here, we review the clinical data on BF-200 ALA for AK along with a summary of molecular mechanisms and future perspectives.
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Topical BF-200 ALA followed by red light irradiation 3 h later induced a significantly higher response rate in AK patients than PDT with 20% solution (Levulan) or 160 mg/g MAL cream (Metvixia).
“Multiple phase III clinical trials demonstrated that topical application of BF-200 ALA followed by red light irradiation 3 h later induced a significantly higher response rate in AK patients than PDT with 20% solution (Levulan) or 160 mg/g MAL cream (Metvixia) [23].”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [23]
BF-200 ALA gel (Ameluz) in combination with red light was approved by the FDA in 2016 for lesion-directed and field-directed treatment of mild-to-moderate severity AK.
“In 2016, BF-200 ALA gel (Ameluz) in combination with red light illumination (centered at ~635 nm) was approved by the FDA for lesion-directed and field-directed treatment of mild-to-moderate severity AK, making it the third ALA-based preparation approved for AK treatment and the only one approved for field-directed treatment.”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [23]
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The stability of 5-aminolevulinic acid and its ester derivatives.
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Flagged first, then by citations
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Nanoparticles for topical drug delivery: Potential for skin cancer treatment
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Daylight Photodynamic Therapy: An Update
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Nanoemulsion applications in photodynamic therapy
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Actinic keratosis: where do we stand and where is the future going to take us?
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5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy
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An overview of randomized phase III clinical trials of cancer nanomedicines
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Investigational drugs currently in phase II clinical trials for actinic keratosis
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Self-citationSchlesinger, T. E., Chapman, M. S., Tu, J. H., Cohen, J. L., Strasswimmer, J., Zeitouni, N. C., Torres, A., Jazayeri, S., Goldman, M. P., Ibrahim, S. F., et al. (2025) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2025.08.031 · Cited by 8 · see citing works
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Current and Emerging Treatment Regimens for HER2-Positive Breast Cancer.
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The Utilization of Nanoemulsified Aminolevulinic Acid in Photodynamic Therapy for Actinic Keratosis
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Current photodynamic therapy and emerging synergies in oncology
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Thérapie photodynamique topique en dermatologie
MORDON, S. (2026) · EMC - Dermatologie · doi:10.1016/s0246-0319(25)50905-6
Terapia fotodinámica tópica en dermatología
MORDON, S. (2026) · EMC - Dermatología · doi:10.1016/s1761-2896(26)51747-3
- Authors
- Reinhold, U.
- Affiliations
- University Hospital Bonn (DE)
- Corresponding author
- Reinhold, Uwe
- ORCID
- Reinhold, Uwe
- Venue
- Future Oncology
- Publisher
- Informa UK Limited
- Published
- 2017-08-14
- Volume
- 13
- Issue
- 27
- Pages
- 2413-2428
- ISSN
- 1479-6694 (ISSN-L)
- 1744-8301
- OpenAlex
- W2748743039
- Cited by
- 46
- References
- 97
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 7 · 2023: 5 · 2022: 5 · 2021: 9 · 2020: 3 · 2019: 7 · 2018: 3 · 2014: 1
- FWCI
- 0.47
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Future Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Keywords
- 5-aminolevulinic acid, photodynamic therapy, actinic keratosis, nanoemulsions, field cancerization, squamous cell carcinoma prevention, stratum corneum penetration
- MeSH terms
- Theranostic Nanomedicine, Aminolevulinic Acid, Emulsions, Humans, Light, Photochemotherapy, Severity of Illness Index, Treatment Outcome, Photosensitizing Agents, Clinical Trials, Phase III as Topic, Keratosis, Actinic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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