PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

Inclusion criteria

• Male or female age > 18 years old.
• Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
• Subject or caregiver capable of performing the skin preparation and Luxerm® treatment application as per the investigator instructions.
• Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
• Female subject of non-childbearing potential, e.g.: post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
• Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
• Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
• Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.

Exclusion criteria

• Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
• Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
• Subject with clinical diagnosis of other skin disease on the target anatomical area.
• Subject with pigmented AK on the target anatomical area.
• Subject with melanoma at any location.
• Immunocompromised subject or requiring immunosuppressive therapies.
• Subject with porphyria; photosensitivity- related disorders, active infectious disease.
• Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
• Female subject who is pregnant, nursing or planning a pregnancy during the study.
• Subject who has used any of the following topical preparations on the area to be treated: keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
• Subject with a wash-out period from baseline for topical or systemic treatment or medical/surgical procedure in the anatomical area (for AKs) less than the following:

• Retinoids, including tazarotene, adapalene, tretinoin, retinol ==> 4 weeks
• Cryotherapy, diclofenac, corticosteroids or other treatments for AK==> 8 weeks
• Microdermabrasion, laser ablative treatments or chemical peels ==>8 weeks
• 5-FU, imiquimod ==>24 weeks
• Surgical: excision and reconstructive surgery, chemosurgery, ==>12 weeks
• Any Photodynamic Therapy, ingenol mebutate (Pep-005), Radiotherapy and UV radiation therapy==>12 weeks
• Investigational therapies for Actinic Keratoses==>12 weeks
• Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on interferon, opioids, TNF binding proteins, Mycophenolate, small biologics agents)==>12 weeks
• Subject who is currently participating to/ or who has participated in another investigational treatment or device research study within 4 weeks of baseline visit.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• Subject who is unwilling to refrain from use of prohibited medication during the clinical trial (see section 4.3.5).
• Subject who is vulnerable (such as deprived of freedom) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
• Subject with clinically significant abnormal laboratory finding (if any available report) at the baseline visit or medical/surgical condition (other than for actinic keratoses), which might, in the Investigator's opinion, interfere with study evaluations or pose a risk to subject safety during the study.
• The subject is a study site staff member (investigator, study nurse, etc.) or a relative of one.
• Subjects with any condition that may be associated with a risk of poor protocol compliance