This phase II clinical trial aims to treat actinic keratosis with photodynamic therapy.
In May 2016, the French National Agency for the Safety of Medicines and Health Products (ANSM) has officially authorized the start of the phase II clinical trial for assessing the non-inferiority of the PHOS-ISTOS device compared to the classical photodynamic therapy (cPDT) for the treatment of actinic keratosis (record number NCT03076892)
This clinical study was performed in the Dermatology Department of the Lille University Hospital, France under the responsibility of Pr. Mortier, and in Germany at Klinikum Vest under the responsibility of Pr. Szeimies.
47 patients were included (24 patients in Lille, and 23 in Recklinghausen). Complete response rate was greater than 90% at 6 months.
The main advantage of the PHOS-ISTOS device is that almost no pain (less than 0.5 on a 0 - 10 VAS scale) was observed during the illumination. In comparison the pain was greater than 7.0 during the classical photodynamic therapy (cPDT) treatment.
More detailed results will be published soon.
A medical device, developed by Texinov, La Tour du Pin – France (partner of the PHOS-ISTOS program) will be commercially available by late this year.