Participants will be invited to take part in a research study as they have been diagnosed with multiple actinic keratosis lesions (AK). AK usually present as small, rough, dry, scaly and/or crusty patches or papules of the skin that can be skin-coloured pink, red, tan or a combinationof colours and are often easier to feel than see at their earlier stages. AK are commonly diagnosed in adults, particularly in patients aged 45 years and older and are considered to be pre-cancerous lesions.
The research is aiming to investigate the protective effect of an investigational sunscreen known as Anthelios Fluide 100 KA+ UVMune 400, when used together with good sun protection habits (which include staying in the shade during the hours of 11 am and 3 pm, wearing sun-protective clothing, wearing a wide-brimmed hat) in participants with multiple Actinic keratoses's.
Eligible participants will be randomly assigned into 1 of 2 groups - an intervention or control group The study main objective is to evaluate tested sunscreen prevention on actinic keratosis lesions.
Adult outpatients ≥ 60y old with at least 11 clinically typical actinic keratosis lesions, including at least one on the face;
Patient having understood and signed a written informed Consent Form to participate in the study indicating the potential participant's willingness to undergo the study procedures and complete the study.
Atypical actinic keratosis lesions including suspected squamous cell carcinoma and basal cell carcinoma (could be present at screening and treated but cannot be present at 1st visit);
History of >2 squamous cell carcinomas;
Known history of immunodepression whatever its cause in the past year;
Participants who cannot undergo skin biopsies, with a history of scarring problems or who have developed adverse effects from the use of local anesthesia will also be excluded.
Parallel
Tested product group
Other interventionThe investigational sunscreen will be applied at least once every morning. Product will be re-applied every 2 hours in case of prolonged exposure or when the likelihood of sunscreen having been removed is high, such as after sweating, water immersion, friction from clothing and exfoliation from sand. The investigational product should be applied on all exposed areas. Scalp, face (avoiding eye contours), neck, forearms, back of the hands, and décolleté will be treated every day . The recommended application dose is 2 mg/cm².
Control group
Other interventionParticipants will be allowed to use the preferred sunscreen (a broad spectrum sunscreen with an SPF of at least 50+) as per their usual routine (every 2 hours and after swimming or exercice).
The full body number of Actinic Keratosis lesions
Actinic Keratosis clinical evaluation (total number of lesions and severity and location will be recorded)
Variation of the photoprotection index (SEPI) - questionnaire
Scoring instrument for assessments of sun habits and sun protection behaviour. It consists of 2 parts: part I addressing the present behaviour and part II addressing propensity to increase sun protection based on the Transtheorical Model of Behaviour Change.
Variation of layers' thickness on Actinic Keratosis lesions
Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Thickness of layers (in µm)
Variation of biomarkers of disease severity (p53)
using skin biopsy (for morphology, immunohistochemistry) in a subset of participants (10 patients per group)
Questionnaire (self-assessment)
Questions on cosmeticity, efficacy and tolerability of the investigational product tested will be completed by patients. 5 different responses will be proposed (Disagree, Disagree partly, Neither agree neither disagree, Agree and Fully agree)
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