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Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy — Flexithera  

Keratosis, Actinic Clinical Trial

Official title:
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)

Clinical Trial Summary

This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.

Clinical Trial Description

The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate).

Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03076918
Study type Interventional
Source University Hospital, Lille
Contact
Status Terminated
Phase N/A
Start date September 2014
Completion date February 2017
View Details
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