This was a PMCF investigation for a MD CE marked and used in its intended purpose with additional procedure non-invasive or non-burdensome.~This was a monocentric, single-blind, randomized, and controlled study performed with intra-individual comparisons. It is a type 2 Interventional study with minimal risks and constraints.~At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense sun exposure were included in the study. The subjects were recruited via the CPCAD Subject Database or from those who spontaneously come to the CPCAD.~At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each subject. The other side was not treated. Then, 15 minutes after application, both sides were irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).~UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical, colorimetrical and photographs) were performed each day. Last assessments were perfomed at Day 8.
The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA.~The secondary objective of this Clinical Investigation was to assess the local safety and the overall tolerability of the test MD on the basis of AE/SAE reporting.