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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
PN+HA (Newest) is a viscoelastic, sterile, single-use gel for intradermal use. PN+HA is a medical device containing the combination of polynucleotides (10 mg/ml) and hyaluronic acid (10 mg/ml). PN+HA is administered using a fine needle (usually 30 G) by injecting the solution into the dermis. Depending on the medical assessment, different injection techniques such as linear threading, serial punctures, crosslinked, radial fanning or mixed can be used. The injection site must consist of healthy skin. PN+HA can also be administered by means of non-invasive techniques (iontophoresis, electroporation, hydroelectrophoresis, etc.). In all these cases, thoroughly cleanse and disinfect the area to be treated before application. Then remove the disinfectant with sterile saline.
Clinica di Chirurgia plastica e ricostruttiva/Ospedale Policlinico San Martino
Genova, Italy, Italy
Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator
To evaluate the performance of PN + HA (Newest) on the aesthetic appearance of the skin 4 months after the last treatment, the change in the Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse) from V4 to baseline (pre-treatment), will be assessed. The GAIS will be completed by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each treated area for all enrolled subjects.
Time frame: At the enrollment and after 4 months from the last treatment.
Investigator and Subject GAIS at each visit
To evaluate the performance of PN + HA (Newest) on the aesthetic appearance of the skin, the change in the Global Aesthetic Improvement Scale (GAIS), rated on a 5-point scale (1= very much/extremely improved; 2= much improved; 3= improved; 4= no change; 5= worse), will be assessed at each visit. The GAIS will be completed independently by the Investigator and the Subject.
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN + HA (Newest) on the skin hydration at each visit
To evaluate the performance of PN + HA (Newest) on skin hydration at each visit, the MoistureMeterEpiD, which displays percentage water content (0 - 100 %), will be used by the Investigator.
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN + HA (Newest) on the skin elasticity at each visit
To evaluate the performance of PN + HA (Newest) on the skin elasticity at each visit, the ElastiMeter, which measures skin elasticity in N/m, will be used by the Investigator at each visit.
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN + HA (Newest) on skin turgor at each visit
To evaluate the performance of PN + HA (Newest) on skin turgor at each visit, a 5-Likert scale (1 - Very poor, 2 - Poor, 3 - Good, 4 - Very good, 5 - Excellent) will be used by the Investigator at each visit.
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Pain intensity after injection of PN + HA (Newest)
To evaluate pain intensity after injection of PN + HA (Newest), a Numerical Rating Scale (NRS), a 0 to 10 scale indicating the degree of pain the patient experienced (0 - No Pain, 5 - Moderate Pain, 10 - Worst possible Pain), will be used at Visit 0 (Baseline), Visit 1 and Visit 2.
Time frame: During the injection procedures
Subject satisfaction with PN + HA (Newest)
To evaluate subject satisfaction with PN + HA (Newest), a 5-Likert scale, from 1 to 5 indicating how satisfied is the patient (1 - Extremely dissatisfied, 5 - Extremely satisfied), will be used at Visit 3 and at End of study (Visit 4)
Time frame: 2 months after last treatment and 4 months after the last treatment
Device deficiencies
A Device Deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. This definition includes device deficiencies related to PN + HA (Newest). Any DD will be assessed by the Investigator at Baseline (Visit 0), Visit 1, and Visit 2.
Time frame: During the injection procedures
Adverse events, serious adverse events and concomitant medications monitoring
Adverse events, serious adverse events and concomitant medications will be monitored during the entire study duration. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
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