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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 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.

International audience; A homogeneous and reproducible fluence rate delivery during clinical PDT plays a determinant role in preventing under-or overtreatment. In Dermatology, topical PDT has been carried out with a wide variety of light sources delivering a broad range of light doses. However, these light sources do not deliver a uniform light distribution on the skin due to their structure and morphology and the complexities of the human anatomy. The development of a flexible light source able to generate uniform light on all its surface would considerably improve the homogeneity of light delivery. The integration of plastic optical fibers (POF) into textile structures offers an interesting alternative. The homogeneous light side-emission from the fabric is obtained by controlling the bending angles of POF inside the LEF due to specific architecture generated by knitting of textile structure. LEF of different surfaces can be easily manufactured (up to 500cm² The LEF thickness is less than 1 mm. The mean irradiance is typically 2.5 mW.cm-².W-1 with heterogeneity of 12.5 % at any point of the LEF. The temperature elevation remains below 1°C. These LEF were evaluated in Dermatology for the treatment of Actinic Keratosis. Two clinical evaluation were performed. The first one was a monocentric, randomized, controlled, phase II clinical study (ClinicalTrials.gov Identifier: NCT03076918). Twenty five (25) patients with grade I-II actinic keratosis (AK) of the forehead and scalp were treated with methyl aminolevulinate photodynamic therapy in two symmetrical areas. One area was treated with the conventional LED panel (154 AK), whereas the other area was treated with the LEF device (156 AK). The second clinical was performed in 2 centers. This new LEF device was a more ergonomic and compact version of the original system developed for FLEXI-PDT. In this clinical study (ClinicalTrials.gov Identifier: NCT03076892), the irradiance has been reduced from 12.3 mW/cm 2 to 1.3 mW/cm 2 and the light dose from 37 J/cm 2 to 12 J/cm 2. Compared to Conventional PDT, the 2 protocols clearly shown that LEF are equivalent and even superior in terms of efficacy for treating AK of the forehead and scalp. However, the use of LEF resulted in much lower pain scores and fewer adverse effects. In conclusion, thanks to LEF, PDT of AK can be conducted in all weather conditions, in any geographic location, year-round and benefits from the optimal adaptability of the flexible, light-emitting, fabrics to the treatment area. At last, LEF can be easily can be easily manufactured in large series.

BACKGROUND Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT). OBJECTIVE The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK. METHODS In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm2) for 2.5 hours so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after MAL application. Recurrent AK at 3 months is retreated. The primary end point is the lesion complete response rate at 3 months. Secondary end points include pain scores at 1 day, local tolerance at 7 days, lesion complete response rate at 6 months, cosmetic outcome at 3 and 6 months, and patient-reported quality of life and satisfaction throughout the study. A total of 45 patients needs to be recruited. RESULTS Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019. CONCLUSIONS In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK. CLINICALTRIAL ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12990

In aesthetic dermatology, photodynamic therapy (PDT) is ideal for reducing signs of aging, hyperpigmentation and fine lines, and thus creating a more youthful complexion. In order to ensure a long-term success, repeated PDT sessions are important. A limitation of PDT in aesthetics may be, in some cases, the pain with conventional (red light) PDT. In these cases, the implementation of intense pulsed light-PDT or natural daylight-PDT may be useful. However, with the simultaneous presence of other non-melanoma skin cancer lesions (e.g. Bowen's disease and basal cell carcinoma) in the treatment area, classical PDT with red light is recommended, because only this approach represents clearly defined treatment protocols.