Abstract
Introduction
Phototherapy and photodynamic therapy (PDT) are ultraviolet light (UV) based therapies for patients with skin diseases, and are sometimes associated with potential adverse events (AE)s, including erythema, pain, pruritus, burns, and photoaging.
Methods
We investigated UV phototherapy and PDT safety using the United States (US) Food and Drug Administration’s (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database, including medical device reports (MDR)s informed by voluntary and obligatory reporters since 1991, was searched for AEs associated with UV phototherapy and PDT 1/1/91–3/1/23.
Results
There were 59 UV phototherapy and 33 PDT related MDRs. Burns were the most common AE type for both phototherapy and PDT. The majority of phototherapy AEs occurred during 2021 (52.3%), and were significantly more likely to occur at home than in the clinic. Overall, 76.1% of MDRs associated with home light boxes were prescribed by online retailers, most of the MDRs (59.3%) mentioned that it is prohibited to sell phototherapy devices not prescribed by physicians, and only 8.5% noted poorly written home light box instructions.
Discussion
The COVID-19 pandemic prohibited in-person light treatments, and social distancing requirements may have resulted in increased frequency of home-based light treatments. Hence, while at home treatment may be easier and more accessible, in-office physician supervised UV treatments are associated with less frequent AEs. Moreover, some phototherapy MDRs reported poorly written instructions accompanying the home light box, and some PDT MDRs documented patients receiving inadequate education regarding the procedure. With the rise of at-home treatment options and the ease of obtaining devices on the internet, it is physicians’ duty to advise patients against self-treating with home light boxes without prescribed treatment regimens and educate patients that are considering home phototherapy to ensure safer patient experiences.
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Data availability
The data that supports the findings of this study are available from the corresponding author Dr. Shari R. Lipner (shl9032@med.cornell.edu) upon request.
Abbreviations
- UV:
-
Ultraviolet light
- PDT:
-
Photodynamic therapy
- AE:
-
Adverse event
- US:
-
United States
- FDA:
-
Food and Drug Administration
- MAUDE:
-
Manufacturer and User Facility Device Experience
- MDR:
-
Medical device report
- MAL:
-
Methyl aminolaevulinate
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SJA and SRL contributed to the design and implementation of the research, to the analysis of the results and to the writing of the manuscript.
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Ms. Albucker has no relevant conflicts of interest to disclose. Dr. Lipner has served as a consultant for Ortho Dermatologics, Hoth Therapeutics, BelleTorus Corporation, and Moberg Pharmaceuticals.
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Albucker, S.J., Lipner, S.R. The burning truth about light therapy: a retrospective analysis of the MAUDE database on UV phototherapy and photodynamic therapy complications 2013–2023. Arch Dermatol Res 316, 51 (2024). https://doi.org/10.1007/s00403-023-02765-5
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DOI: https://doi.org/10.1007/s00403-023-02765-5