A phase II study evaluating the non-inferiority of a photodynamic therapy protocol involving the Flexitheralight device compared to the conventional protocol. (FLEXITHERALIGHT Study) (Preprint)
Authors: Lecomte Fabienne , VIGNION Anne Sophie , VICENTINI Claire , THECUA ELISE , DELEPORTE Pascal , DUHAMEL ALAIN , MORDON SERGE , MORTIER LAURENT 
Published: July 2018

BACKGROUND

Actinic Keratosis (AK) are common pre-invasive cancerous lesions in sun-exposed skin, which negatively affect the quality of life in patients and may progress to invasive squamous cell carcinoma (SCC). Studies have shown that if untreated, AK may regress, or alternatively, may progress to SCC, with significant morbidity and possible lethal outcome. The most commonly used treatments for AK are cryotherapy, topical chemotherapy and, more recently, photodynamic therapy (PDT). This clinical study is part of a project, which aims at the creation of specific light emitting fabrics (LEF) in order to strongly improve the efficiency and reliability of PDT

OBJECTIVE

This study aims to compare the effectiveness and tolerability of a new PDT protocol involving the device Flexitheralight (N-PDT) versus the classical protocol involving the device Aktilite®128 (Galderma) (C-PDT) for the treatment of AK. All participants receive both protocols.
The primary objective is to compare the lesion response rate at 3 months of N-PDT versus C-PDT.
Secondary objectives are the evaluation of the pain and local tolerance during treatment, the clinical evolution of the subject's skin aspect, the quality of life and satisfaction of patients.

METHODS

The study is a split-face intra-individual comparison of two PDT protocols. The number of patients to be recruited is 42. Patients are exposed to a continuous red light spectrum with Aktilite®128 on one face, and, to a fractionated illumination with the new device Flexitheralight on the other face.
Males or females over the age of 18 years with a clinical diagnosis of at least 10 previously untreated, non-pigmented, non-hyperkeratotic AK of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991) are included in the department of dermatology of the Lille University Hospital. The patients come to the investigational center for one treatment session (Day 1) and they are followed at Day 7, Month 3 and Month 6. A second session of treatment can be performed at Day 111 in case of incomplete response at Month 3. Data are analysed using SAS software version 9.4 (SAS Institute Inc., Cary, North Carolina, USA). Continuous variables are expressed as the mean and standard deviation and categorical variables are expressed as the frequency and percentage. The Shapiro-Wilk test will be used to assess the normality of the distribution.

RESULTS

Investigations are achieved but data analysis is ongoing. The statistical results will be analyzed by the end of 2018

CONCLUSIONS

In case of non-inferior efficiency and better tolerability than C-PDT, N-PDT could become the treatment of choice for AK. Moreover, N-PDT is easy to implement in hospitals.

CLINICALTRIAL

N° ID-RCB 2013-A01096-39
Number Clinical Trial (NCT) NCT03076918
Protocol version 2.0 date 23.02.2015