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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours
CHRU, Hôpital Claude Huriez
Lille, France
Klinikum Vest Gmbh
Recklinghausen, Germany
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: at Day 1 and Day 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: at Month 3 and Month 6
Rate of patients with at least 75% of reduction of the lesions
The response rate is calculated in relation to the initial number of lesions: Response rate is validated if rate ≥ 4 lesions destroyed for 5 initial lesions, ≥ 5 for 6 lesions and ≥ 6 for 7 lesions
Time frame: at Month 3 and Month 6
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 1 , Day 7, Month 3 and Month 6
Satisfaction autoquestionnaire
The questionnaire is created by investigator to evaluate the comfort of device. Participants will answer 9 questions on a 5-point scale that ranged from Not embarrassing,few embarrassing, Embarrassing, Very embarrassing, Don't know
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Time frame: at Day 7, Month 3 and Month 6