Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration

Exclusion Criteria

• •1. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy);
• •2. Infectious or inflammatory processes near the area of intervention;
• •3. Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;
• •4. Presence of tendon, bone or muscular implants near the area of intervention;
• •5. Ongoing cutaneous allergies;
• •6. Allergy or contraindications to device components;
• •7. Concomitant intake of anticoagulant or antiplatelet medications;
• •8. Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
• •9. Immune system illnesses/disease;
• •10. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
• •11. Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;
• •12. Known drug and/or alcohol abuse;
• •13. Mental incapacity that precludes adequate understanding or cooperation;
• •14. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months prior to study inclusion;
• •15. Pregnancy or breastfeeding;
• •16. Participation in another investigational study within 1 month prior to study inclusion.