Actinic keratosis of the scalp Traitment

Phase 1

Conditions: actinic keratosis
MedDRA version: 18.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-003602-32-FR

Lead Sponsor: CHU de Limoges

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

•Clinical diagnosis of at least 10 previously untreated AK lesions of Grade 1 and/or 2 of the scalp (at least 5 KA at each hlf of the scalp)
•Males or females above 18 years of age.
•Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Patients with porphyria.
-Known allergy to metvixia® compound or excipients of the cream.
-Patients with history of hypersensitivity to nut products
-Patients receiving local treatment in the scalp areaea within the last 30 days.
-Patients receiving topical treatment,chemotherapy or immunotherapy in scalp area within the last 2 months.
-Sclerodermiform / nodular basal cell/intraepithelial carcinoma in the treated area
-Pregnant or breast-feeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate clinical efficacy of daylight photodynamic therapy using Metvixia®compared to conventional PDT treatment using Metvixia®;Secondary Objective: 1 To assess the safety of treatment <br>2 To assess the clinical efficacy at 1 month and 6 months post treatment<br>3 To assess the appearance of new keratoses 1 month rate, 3 months and 6 months <br>4 To consider the possible relationship between treatment efficacy at 1 month, 3 months and 6 months depending on the amount of light received;Primary end point(s): Number of disapeared Actinic Keratosis at 3 month;Timepoint(s) of evaluation of this end point: At 3 month

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day 0, 1 month, 3 month ant 6 month;Secondary end point(s): - To evaluate the safety of treatment (questionnaire and pain assessment)<br>- The disappearance rate at 1 month and 6 months (relative to the layer of the inclusion visit)<br>- The emergence of new keratoses at 1 month and 6 months (new KAappeared) rates.<br>- The relationship between dose of sunlight received, measured by the luxmeter worn by the patient at the time of exposure, and clinical<br>efficacy 1 month, 3 months and 6 months