Spots Global Cancer Trial Database for Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

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Trial Identification

Brief Title: Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

Official Title: A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)

Study ID: NCT03076892

Conditions

Keratosis, Actinic

Interventions

Aktilite® Galderma

PHOS ISTOS PDT

Study Description

Brief Summary: This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp

Detailed Description: The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled