Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 29, 2018
Open Peer Review Period: Dec 5, 2018 - Dec 19, 2018
Date Accepted: Feb 7, 2019
(closed for review but you can still tweet)
A protocol involving a new light-emitting, fabric-based device (the Phosistos protocol) versus the conventional protocol for photodynamic therapy of actinic keratosis − a randomized, controlled, multicentre, intra-individual, phase II non-inferiority study.
ABSTRACT
Background:
Actinic keratosis (AK) is a common precancerous skin lesion caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. In order 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 non-inferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device, the Phosistos protocol (P-PDT), compared to the conventional protocol (C-PDT) in the treatment of AK.
Methods:
In this randomized, controlled, multicentre, intra-individual, phase II non-inferiority 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 2h30 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 incubation with MAL. Recurrent AK at three months are retreated. The primary endpoint is the lesion complete response rate at three months. Secondary endpoints include pain scores at one day, local tolerance at seven days, lesion complete response rate at six months, cosmetic outcome at three and six months, and patient-reported quality of life and satisfaction throughout the study. Forty-five patients need 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 non-inferiority in efficacy and superiority in tolerability of P-PDT compared to C-PDT, P-PDT could become the treatment of choice for AK. Clinical Trial: The study was registered in ClinicalTrials.gov under identifier NCT03076892 (date of registration: March 10, 2017).
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