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Summary: Background: Topical photodynamic therapy (PDT) using methyl aminolaevulinate is a noninvasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The most widely used, conventional protocol in Europe includes illumination with a red‐light lamp. This illumination commonly causes pain, and patients often cannot complete the treatment. Objectives: The aims of this paper are twofold. The first aim is to introduce a novel protocol, the Phosistos protocol (P‐PDT), which includes illumination with a fabric‐based biophotonic device. The second and major aim is to assess the noninferiority, in terms of efficacy for PDT of AK, of P‐PDT compared with the conventional protocol (C‐PDT). Methods: A randomized, controlled, multicentre, intraindividual clinical study was conducted. Forty‐six patients with grade I–II AK of the forehead and scalp were treated with P‐PDT on one area (280 AK lesions) and with C‐PDT on the contralateral area (280 AK lesions). The primary end point was the lesion complete response (CR) rate at 3 months, with an absolute noninferiority margin of −10%. Secondary end points included pain scores, incidence of adverse effects and cosmetic outcome. Results: Three months following treatment, the lesion CR rate of P‐PDT was noninferior to that of C‐PDT (79·3% vs. 80·7%, respectively; absolute difference −1·6%; one‐sided 95% confidence interval −4·5% to infinity). The noninferiority of P‐PDT to C‐PDT in terms of the lesion CR rate remained at the 6‐month follow‐up (94·2% vs. 94·9%, respectively; absolute difference −0·6%; one‐sided 95% confidence interval −2·7% to infinity). Moreover, the pain score at the end of illumination was significantly lower for P‐PDT than for C‐PDT (mean ± SD 0·3 ± 0·6 vs. 7·4 ± 2·3; P < 0·001). Conclusions: P‐PDT is noninferior to C‐PDT in terms of efficacy for treating AK of the forehead and scalp and resulted in much lower pain scores and fewer adverse effects. What's already known about this topic? Topical photodynamic therapy using methyl aminolaevulinate is effective for treating actinic keratosis.In Europe, the conventional protocol involves illumination with a red‐light lamp. Unfortunately, pain is often experienced by patients undergoing this protocol.An alternative protocol that uses daylight illumination has recently been shown to be as effective as the conventional protocol while being nearly painless. However, this alternative protocol can be conducted only in suitable weather conditions. What does this study add? The Phosistos protocol is demonstrated to be as effective as the conventional protocol, nearly as painless as the daylight protocols and suitable year round for treatment of actinic keratosis. Plain language summary available online Linked Comment: Gilaberte. Br J Dermatol 2020; 182:11–12. [ABSTRACT FROM AUTHOR]

Summary: Background: Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light‐emitting, fabric‐based device was developed. Objectives: This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp. Methods: A monocentric, randomized, controlled, phase II clinical study was performed. Twenty‐five patients with grade I–II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end‐point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of –10% was used). The secondary end‐points included patient‐reported pain at the end of the irradiation. Results: At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval –0·6% to 14·5%). Patient‐reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001). Conclusions: The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp. What's already known about this topic? Methyl aminolaevulinate photodynamic therapy (PDT) is an effective and noninvasive treatment for actinic keratosis (AK).Treatment‐associated pain is frequently experienced by patients treated with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.PDT using daylight as the activating light source has been confirmed as equally effective and less painful than the conventional protocol, but it cannot be performed in all weather conditions. What does this study add? This study demonstrates that the Flexitheralight protocol, which can be performed in all weather conditions, is equally effective as the conventional PDT protocol for AK and is a less painful technique. Linked Comment:Morton. Br J Dermatol 2019; 180:703–704. Respond to this article Plain language summary available online [ABSTRACT FROM AUTHOR]

Summary: Actinic keratoses (AKs) are areas of sun‐damaged skin found mainly on sun‐exposed parts of the body, particularly the backs of the hands and forearms, the face and ears, and the scalp in balding men. They are usually harmless although they can be unsightly or inconvenient, and there is a very small risk of some actinic keratoses progressing to a form of skin cancer called squamous cell carcinoma. There are several possible treatments, including photodynamic therapy (PDT), in which a special light activates a cream called a photosensitiser, which has been applied to the affected area of skin. This treatment kills the abnormal cells in the skin. The photosensitisers approved in Europe for PDT of AKs require either activation by red light three hours after application of the photosensitiser (referred to as C‐PDT) or activation by daylight within 30 minutes following application of the photosensitiser (referred to as D‐PDT). The major drawback of C‐PDT is pain during treatment, whereas D‐PDT is nearly pain‐free due to the short time between photosensitiser application and daylight activation. Unfortunately, D‐PDT requires favourable weather conditions. The authors of this study, who belong to the ONCO‐THAI research unit based in France, therefore tested a way to activate the photosensitiser 30 minutes after application, by red light using a flexible, light‐emitting, fabric‐based device (hereinafter referred to as FLEXI‐PDT). This study aimed to assess whether FLEXI‐PDT is at least as effective as C‐PDT in destroying AK. The authors were also interested in whether pain scores differ between FLEXI‐PDT and C‐PDT. For these purposes, 35 patients with AKs on the scalp were treated with FLEXI‐PDT on one side of the scalp and with C‐PDT on the other side. Patients rated their pain during FLEXI‐PDT and during C‐PDT separately. The response of each AK (complete or incomplete disappearance) was assessed by a dermatologist at three months after treatment. From the analyses of the data collected, the authors showed that FLEXI‐PDT, which can be performed in all weather conditions, is at least as effective as and less painful than C‐PDT in destroying AK. Linked Article: Vicentini et al. Br J Dermatol 2019; 180:765–773 [ABSTRACT FROM AUTHOR]