Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

Exclusion Criteria

• •Patients with porphyria.
• •Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
• •Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
• •Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
• •Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
• •Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.
• •Pigmented AK lesion(s).
• •Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
• •Participation in other clinical studies either currently or within the last 30 days.
• •Female subjects must be of either:
• •* Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
• •* Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy.
• •Any condition which may be associated with a risk of poor protocol compliance.
• •Patients currently receiving regular ultraviolet radiation therapy.