NCT03076892

Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DEVICE	Aktilite® Galderma	preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
DEVICE	PHOS ISTOS PDT	preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2017-03-10
• Last updated: 2017-11-14

Locations

2 sites across 2 countries: France, Germany