Spots Global Cancer Trial Database for Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

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Trial Identification

Brief Title: Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

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

Study ID: NCT03076918

Conditions

Keratosis, Actinic

Interventions

FLEXITHERALIGHT PDT

Aktilite® Galderma

Study Description

Brief 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®.

Detailed 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.