Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes

Aktilite® Galderma

preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

PHOS ISTOS PDT

Laurent Mortier, MD, PhD

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

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)

Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed

measure the pain and local tolerance graduation range 0 to 10.

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

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

The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS	NCT03076892	Keratosis, Acti...	Aktilite® Galde... PHOS ISTOS PDT	18 Years -	University Hospital, Lille
Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS	NCT03076892	Keratosis, Acti...	Aktilite® Galde... PHOS ISTOS PDT	18 Years -	University Hospital, Lille

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