Efficacy and Safety of PN20 (Plinest) for the Improvement of Skin Hydration

A Post-market, Monocentric, Interventional, Single-arm, Confirmative Clinical Investigation to Evaluate the Performance and the Safety of PN20 (Plinest) for the Improvement of Skin Hydration

This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN20 (PLINEST) 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 PN20 in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté, making sure that at least 14 areas for face, neck and décolleté 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 each area treated) at each visit.

Skin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.

Skin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.

At V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).

Subject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).

Safety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.

Inclusion Criteria:

1. Subject Informed consent form (ICF) signed;
2. Female and male Subjects aged 18-70 years;
3. Subjects desiring improvement of skin hydration in maximum 2 areas of the face, or 1 area of the face plus neck or décolleté;
4. Healthy skin;
5. Willingness to discontinue all dermatological treatment and procedures during the study;
6. Willingness to follow all study procedures, including attending all site visits, tests and examinations;
7. Agreeing to present at each study visit without face/neck/ décolleté cosmetics;
8. Accepting to not change their habits regarding food, physical activity, face/neck/décolleté cosmetics and cleansing products;
9. Willingness to follow indications to minimize exposure of the treated area to too much sunlight or extreme cold, at least until the papules have completely subsided;
10. Skin phototype I-IV according to Fitzpatrick's classification.

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.