A randomized split-face clinical trial of conventional vs indoor-daylight photodynamic therapy for the treatment of multiple actinic keratosis of the face and scalp and photoaging

Arisi, Mariachiara; Spiazzi, L.; Pisani, Edoardo Guasco; Venturuzzo, Anna; Rovati, Chiara; Tomasi, Cesare; Venturini, Marina; Calzavara‐Pinton, Piergiacomo

doi:10.1080/09546634.2021.1944594

Cited by 8 publications

(16 citation statements)

References 21 publications

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“…A recent randomized split-face controlled study from our department has compared the effectiveness, tolerability and patient preference of c-PDT and idl-PDT with a white LED lamp (Dermaris, Surgiris, Croix, France) for grade I–II AKs of the face and scalp [ 26 ]. The study showed the lack of inferiority and the better tolerability of idl-PDT compared with c-PDT, with the former being found to be the preferred treatment for patients.…”

Section: Discussionmentioning

confidence: 99%

“…Daylight PDT (dl-PDT) has been demonstrated to represent a valuable treatment option with similar efficacy to and less pain and inflammation than c-PDT [9,15,19,[22][23][24], although comparative studies are not available so far. In this setting, the MAL or ALA cream is applied without occlusion for 30 min and then the lip is exposed to direct or indirect solar radiation for 2 h [26].…”

Section: Introductionmentioning

confidence: 99%

“…Indoor dl-PDT (idl-PDT) is a new PDT treatment protocol that differs from dl-PDT only because the patient is treated indoors with exposure to an artificial broadband white light source instead of outdoors with natural daylight [26]. The advantages are the delivery of a standard light dose and the avoidance of environmental variability [26,[29][30][31].…”

Section: Introductionmentioning

confidence: 99%

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Randomized Clinical Trial of Conventional versus Indoor Daylight Photodynamic Therapy for Treatment of Actinic Cheilitis

Arisi

Galli

Pisani

et al. 2022

Dermatol Ther (Heidelb)

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Introduction: Actinic cheilitis (AC) is the biologic precursor of invasive squamous cell carcinoma (SCC) of the vermilion, and different treatment options have been investigated, but their efficacy is hampered by local inflammation, pain and slow recovery. Daylight photodynamic therapy (dl-PDT) has been demonstrated to represent a valuable treatment option for AC, but its feasibility is limited by weather conditions and latitude. Methods: Our study proposed to compare the efficacy and tolerability of conventional photodynamic therapy (c-PDT) and indoor daylight photodynamic therapy (idl-PDT) with a white LED lamp for the treatment of AC. Sixteen patients were enrolled in the study: 8 (50%) treated with c-PDT and 8 (50%) treated with idl-PDT. All patients completed the study protocol. Results: Both idl-PDT and c-PDT were demonstrated to be highly effective in terms of reduction of the cumulative lesional area and severity of the clinical score. Neither treatment was inferior to the other. The inflammatory reaction and the pain scores were milder with idl-PDT, whereas the cosmetic outcome was not different. Conclusion:The present findings confirm that idl-PDT can represent a valid therapeutic strategy for AC patients as well, despite the procedural difficulties and the risk of poor tolerability related to the body site.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomized Clinical Trial of Conventional versus Indoor Daylight Photodynamic Therapy for Treatment of Actinic Cheilitis

Arisi

Galli

Pisani

et al. 2022

Dermatol Ther (Heidelb)

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“…As a possible solution to these limitations, indoor daylight PDT has been developed. The treatment protocol, efficacy, and tolerability are the same of conventional PDT but, differently from dl-PDT, the skin is exposed to an artificial broad-band white light source indoors and not to direct sunlight outdoors [26]. Tirbanibulin (TIR) was recently approved by the European Medicines Agency and, at present, is being marketed in the UK, Germany, and the USA and it will likely be available in other European countries in a few months [27].…”

Section: Treatment Options For Aksmentioning

confidence: 99%

Section: Treatment Options For Aksmentioning

confidence: 99%

Topical Pharmacotherapy for Actinic Keratoses in Older Adults

Calzavara‐Pinton

Rovati

2022

Drugs Aging

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Actinic keratosis is caused by excessive lifetime sun exposure. It must be treated, regardless of thickness, because it is the biologic precursor of invasive squamous cell carcinoma, a potentially deadly malignancy. Physical ablative techniques such as cryotherapy, lasers, and curettage are the most used treatments for isolated lesions. Multiple lesions are treated with topical drugs, chemical peelings, and physical techniques. Drug preparations containing diclofenac plus hyaluronate, aminolevulinic acid, and methyl aminolevulinate and different concentrations of imiquimod and 5-fluorouracil are approved for this clinical indication. All treatments have a good profile of efficacy and tolerability although there are relevant differences in the clearance rate, tolerability, and type and frequency of adverse effects. In addition, they have very different mechanisms of action and treatment protocols. No differences in the efficacy and tolerability were found in older patients compared with younger patients, therefore no dose adjustments are needed. That said, older patients often need to be motivated to treat actinic keratoses and a careful attention to expectations, needs, and preferences should be used to obtain the maximal adherence and prevent treatment failure. This goal can be achieved with a careful evaluation not only of published efficacy, toxicity, and tolerability data but also of practical topics such as the frequency of daily applications, the overall duration of therapy, and the need for a caregiver. Finally, particular attention must be paid in the case of frail patients and immunosuppressed patients.

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Equivalent efficacy of indoor daylight and lamp‐based 5‐aminolevulinic acid photodynamic therapy for treatment of actinic keratosis

Ruiz

LaRochelle

Fahrner

et al. 2023

Skin Health and Disease

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Background Photodynamic therapy (PDT) is widely used as a treatment for actinic keratoses (AK), with new sunlight‐based regimens proposed as alternatives to lamp‐based treatments. Prescribing indoor daylight activation could help address the seasonal temperature, clinical supervision, and access variability associated with outdoor treatments. Objective To compare the AK lesion clearance efficacy of indoor daylight PDT treatment (30 min of 5‐aminolevulinic acid (ALA) pre‐incubation, followed by 2 h of indoor sunlight) versus a lamp‐based PDT treatment (30 min of ALA preincubation, followed by 10 min of red light). Methods A prospective clinical trial was conducted with 41 patients. Topical 10% ALA was applied to the entire treatment site (face, forehead, scalp). Patients were assigned to either the lamp‐based or indoor daylight treatment. Actinic keratosis lesion counts were determined by clinical examination and recorded for pre‐treatment, 1‐month, and 6‐month follow‐up visits. Results There was no statistical difference in the efficacy of AK lesion clearance between the red‐lamp (1‐month clearance = 57 ± 17%, 6‐month clearance = 57 ± 20%) and indoor daylight treatment (1‐month clearance = 61 ± 19%, 6‐month clearance = 67 ± 20%). A 95% confidence interval of the difference of the means was measured between −4.4% and 13.4% for 1‐month, and −2.2% and +23.6% for 6‐month timepoints when comparing the indoor daylight to the red‐lamp treatment, with a priori interval of equivalence of ±20%. Limitations Ensuring an equivalent dose between the indoor and lamp treatment cohorts limited randomisation since it required performing indoor daylight treatments only during sunny days. Conclusion Indoor‐daylight PDT provided equivalent AK treatment efficacy to a lamp‐based regimen while overcoming temperature limitations and UV‐block sunscreen issues associated with outdoor sunlight treatments in the winter. Clinical trial registration http://Clinicaltrials.gov listing: NCT03805737.

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A randomized split-face clinical trial of conventional vs indoor-daylight photodynamic therapy for the treatment of multiple actinic keratosis of the face and scalp and photoaging

Cited by 8 publications

References 21 publications

Randomized Clinical Trial of Conventional versus Indoor Daylight Photodynamic Therapy for Treatment of Actinic Cheilitis

Randomized Clinical Trial of Conventional versus Indoor Daylight Photodynamic Therapy for Treatment of Actinic Cheilitis

Topical Pharmacotherapy for Actinic Keratoses in Older Adults

Equivalent efficacy of indoor daylight and lamp‐based 5‐aminolevulinic acid photodynamic therapy for treatment of actinic keratosis

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