The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect. By combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.
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Absence of autofluorescence (FAF) laser-light spot
Timeframe: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Absence of NIR-cSLO laser-light spot traces
Timeframe: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Treatment-Emergent Adverse Events (TEAE)
Timeframe: From the first Treatment Session (T0), at each subsequent Treatment Sessions (T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)