Oral Presentation 18th International Congress on Photobiology 2024

Usefulness of the SmartPDT® digital medical device to optimise the effectiveness and safety of natural daylight PDT (NDL-PDT): a clinical study in Spain (#57)

Yolanda Gilaberte 1 , Tamara Gracia-Cazaña 1 , Alba Navarro-Bielsa 1 , Oriol Yelamos 2 , Manuel Almenara-Blaso 1 , Ana J Garcia-Malinis 3 , María Gimenez-Sanmartin 1 , Rowan C Temple 4 , Marco Morelli 4
  1. Miguel Servet University Hospital, Zaragoza, ARAGON, Spain
  2. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  3. Cellular biology, University Autonoma Madrid (UAM), Madrid, Spain
  4. SiHealth Ltd, Harwell Campus, Oxfordshire, United Kingdom

Natural Daylight Photodynamic Therapy (NDL-PDT) is an efficacious treatment of actinic keratosis (AK). However, the use of daylight introduces uncontrolled variability that may influence the effectiveness, such as time of year, cloudiness, sunscreen application and patient behaviour [1]. An innovative satellite-based solution (SmartPDT®) is the first scientifically validated digital medical device (CE-marked Class 1) solving this [2]. The dermatologist can accurately plan and then monitor in real-time the effective (PpIX-effective) and safe (erythemal) solar radiation doses.

An observational, multicentre, prospective study of clinical practice took place in Spain from June 2022 to October 2023. Clinical teams used the SmartPDT® web-portal for monitoring either a hospital-based NDL-PDT or a home-based NDL-PDT performed by the patient using its related mobile app. Follow-up clinical evaluation was performed at 3 months.

Thirty patients were included, 5 females and 32 males, with ages ranging from 51 to 87 years old. All NDL-PDT sessions were performed according to the current clinically-accepted therapy protocol [3], so  exposing patients for exactly 2 hours to sunlight independently from weather conditions. AK severity (AKASI score) was assessed before and 3 months after treatment, considering scalp, forehead, left face and right face separately.

For all body sites considered, PpIX-effective solar doses ranged from 2.98 Jeff/cm2 to 23.8 Jeff/cm2, while erythemal doses ranged from 1.9 Jeff/m2 to 61.84 Jeff/m2. Air temperature ranged from 7.3 ˚C to 39.58 ˚C. A preliminary analysis on the correlation between AKASI variation (i.e. treatment effectiveness) and monitored environmental variables was conducted and we will present its results.

This study demonstrates that a satellite-based digital system can help clinicians to optimise the overall management and effectiveness of NDL-PDT, planning and monitoring the environmental variables affecting its clinical outcomes and safety. This can help to provide a more effective and comfortable treatment with higher therapy adherence.

 

 

  1. [1] Wiegell SR, Gilaberte Y et al. (2011). Daylight photodynamic therapy for actinic keratosis: an international consensus. JEADV 26, 673 [2] McLellan L et al. (2020). SmartPDT®: Smartphone enabled real-time dosimetry via satellite observation for daylight photodynamic therapy. Photodiagnosis Photodyn Ther 31, 101914 [3] Morton CA et al. (2019). European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas. JEADV 33, 2225