The French regulatory agencies (ANSM and CPP) authorize our clinical trial on the photodynamic treatment of the Paget's disease.
On October 25, 2018, the OncoThAI laboratory obtained authorizations from the National Agency for the Safety of Medicines and Health Products (ANSM) and the Committee for the Protection of Persons (CPP) for the start of the PAGETEX study.
This study aims to treat people with extra mammary Paget's disease of the vulva by photodynamic therapy. A new medical device using Light Emitting Fabrics (LEF) technology will be assessed in the dermatology department of Lille University Hospital. A maximum of 24 patients will be enrolled in this phase II clinical trial, which aims to evaluate a disease control rate at 3 months (total and partial response) in 30% of the patients included.
This clinical study is supported by the iLatext project, funded by the FEDER under the FEDER-FSE operational program.
ClinicalTrials website: clinicaltrials.gov/ct2/show/NCT03713203