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. 2019 Apr 26;8(4):e12990.
doi: 10.2196/12990.

A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study)

Anne-Sophie Vignion-Dewalle  1 , Henry Abi Rached  1   2 , Elise Thecua  1 , Fabienne Lecomte  1 , Pascal Deleporte  1 , Hélène Béhal  3 , Theresa Hommel  4 , Alain Duhamel  3 , Rolf-Markus Szeimies #  4 , Laurent Mortier #  1   2 , Serge Mordon  1
Affiliations

A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study)

Anne-Sophie Vignion-Dewalle et al. JMIR Res Protoc. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek).

International registered report identifier (irrid): DERR1-10.2196/12990.

Keywords: Aktilite CL 128 lamp; actinic keratosis; light-emitting fabric; photodynamic therapy.

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Conflict of interest statement

Conflicts of Interest: SM, ASVD, HAR, ET, FL, CV, PD, HB, DK, TH, and AD declare that they have no competing interest. RMS is the vice president of EURO-PDT. He has been a member of advisory boards for Almirall, Biofrontera, Galderma, ISDIN, LEO Pharma, photonamic, and Pierre-Fabre and has received speakers’ honoraria from the aforementioned companies. LM has been a member of advisory boards for BMS, Roche, GSK, Novartis, LEO Pharma, and MSD. He has received travel grants for attending congresses from BMS, Roche, GSK, Novartis, and LEO Pharma. He has been the principal investigator of clinical trials performed for BMS, Roche, GSK, Novartis, LEO Pharma, and MSD.

Figures

Figure 1
Figure 1
The light-emitting, fabric-based device involved in photodynamic therapy using the phosistos protocol: 635-nm red light is emitted at 1.3 mW/cm2 by a fiber optic–based fabric that lines the inside of a cap.
Figure 2
Figure 2
Study flow diagram. V1: first treatment visit; V2: first evaluation visit; V3: second treatment visit; V3bis in case of recurrent actinic keratosis: second treatment visit; V4: third treatment visit.
See this image and copyright information in PMC

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