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Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration

Mastelli S.r.l · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN+HA (NEWEST) for the improvement of skin hydration. Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF. For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart: * V0 (Screening/baseline): Day 0, when the first IP injection will be performed; * V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed; * V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT); * V3: maximum 4 months from V0 and 2 months after the last IP injection (V2); * V4: maximum 6 months form V0 and 4 months after the last IP injection (V2). At V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject. At V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN+HA in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté/back of the hands, making sure that at least 10 areas of face, neck, décolleté and back of the hands will be reached. Local anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject. Performance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per e
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