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®.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes
CHRU, Hôpital Claude Huriez
Lille, France
Treated lesion response rate
Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
Time frame: up to month 6
Visual Analog scale of pain
Measure the pain and local tolerance graduation range 0 to 10
Time frame: Day 1 and D ay 7.
Scale for clinical assessment of the subject's skin aspect
4-point scale that ranged of Excellent; No scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to adjacent skin. Good: No scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin, Fair: Slight to moderate occurrence of scarring, atrophy or induration, Poor: Extensive occurrence of scarring, atrophy or induration
Time frame: Months 3 and Months 6
Fluorescence measure of the PpIX
Measures with Fluoderm photometer
Time frame: Baseline, after 3 hours of incubation, in case of treatment interruption, immediately after the treatment, and at 15 and 30 minutes after the end of the treatment.
Irradiance measure in mW/cm2 for each AK
Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered
Time frame: during Aktilite® treatment at Day 1
Rate of patients with at least 75% of reduction of the lesions
The reduction in the number of lesions will be calculated as a function of the initial number:≥4 destroyed if 5 lésions; ≥ 5 destroyed if 6 lésions and ≥6 destroyed if 7 lesions ≥4 destroyed if 5 lesions
Time frame: Months 3 and Months 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dermatology Life Quality Index (DLQI)
The questionnaire of 10 questions is completed by the patient to evaluate his quality of life
Time frame: At Day 7, Months 3 and Months 6
Satisfaction Questionnaire
The questionnaire es created by the investigator to evaluate the comfort of the device. Patient will give his overall satisfaction and the will answer 7 questions on a 5-point scale that ranged from Not embarrassing, few embarrassing, embarrassing, Very embarrassing, I Don't know
Time frame: At Day 7, Months 3 and Months 6