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

European Commission

Institut National de la Santé Et de la Recherche Médicale, France

University Hospital, Lille

Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours

FLEXITHERALIGHT PDT

Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes

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.

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)

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

Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy	NCT03076918	Keratosis, Acti...	FLEXITHERALIGHT... Aktilite® Galde...	18 Years -	University Hospital, Lille

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