NCT03076918

Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DEVICE	FLEXITHERALIGHT PDT	Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
DEVICE	Aktilite® Galderma	Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-03-10
• Last updated: 2018-05-18

Locations

1 site across 1 country: France