Skin Quality Clinical Trial
Official title:
A Randomized, Controlled, Split-Face Study to Evaluate the Clinical Performance and Safety of KIO015 for Improving Face Skin Hydration
The clinical investigation is designed to primarily confirm the performance of KIO015 in improving skin hydration after superficial intradermal injection. A non-treated zone (untreated hemi-face) will be used as comparator for exact evaluation of the zones between the treated and untreated ones The safety of KIO015 will also be evaluated for confirmation of initial data. For this purpose, 80 healthy subjects will be injected in half of the face. In KIO015-PLUM, healthy subjects with signs of cutaneous aging and dehydrated skin on the face will receive either one or three dermal injections: - Cohort 1: one intradermal injection session of KIO015 device on M0, to evaluate the effect of a single injection session - Cohort 2: three intradermal injection sessions of KIO015 device on M0, M1 and M2, to evaluate the effect of 3 injection sessions as performed for state-of-the-art products.
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