Clinical trial NCT06821867: Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Hydration
Skin Elasticity
Keywords: Skin hydration
Aesthetic improvement
Polynucleotides
PN HPT
Skin elasticity
Skin turgor
Mastelli
Lead sponsor: Mastelli S.r.l
Sponsor class: INDUSTRY
Collaborators: name: 1Med
First posted: 2025-02-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator
timeFrame: At the enrollment and after 4 months from the last treatment.
Secondary outcomes:
measure: Investigator and Subject GAIS at each visit
timeFrame: From enrollment to the end after 4 months from the last treatment (at each visit)
measure: Performance of PN + HA (Newest) on the skin hydration at each visit
timeFrame: From enrollment to the end after 4 months from the last treatment (at each visit)
measure: Performance of PN + HA (Newest) on the skin elasticity at each visit
timeFrame: From enrollment to the end after 4 months from the last treatment (at each visit)
measure: Performance of PN + HA (Newest) on skin turgor at each visit
timeFrame: From enrollment to the end after 4 months from the last treatment (at each visit)
measure: Pain intensity after injection of PN + HA (Newest)
timeFrame: During the injection procedures
measure: Subject satisfaction with PN + HA (Newest)
timeFrame: 2 months after last treatment and 4 months after the last treatment
measure: Device deficiencies
timeFrame: During the injection procedures
measure: Adverse events, serious adverse events and concomitant medications monitoring
timeFrame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Clinica di Chirurgia plastica e ricostruttiva/Ospedale Policlinico San Martino
Study officials:
References:
citation: E. Bartoletti et al., "PN HPTTM and Striae Albae-Exploratory Interim Analysis of a Randomised Prospective Study, " Surgical Research, vol. 5, no. 3, Sep. 2023, doi: 10.33425/2689-1093.1057
citation: Cavallini M, Bartoletti E, Maioli L, Massirone A, Pia Palmieri I, Papagni M, Priori M, Trocchi G; As Members of The Polynucleotides HPT Priming Board, Collegio Italiano delle Societa Scientifiche di Medicina Estetica (Italian College of the Aesthetic Medicine Scientific Societies) - SIME, AGORA, SIES. Consensus report on the use of PN-HPT (polynucleotides highly purified technology) in aesthetic medicine. J Cosmet Dermatol. 2021 Mar;20(3):922-928. doi: 10.1111/jocd.13679. Epub 2020 Sep 21.
citation: De Caridi G, Massara M, Acri I, Zavettieri S, Grande R, Butrico L, de Franciscis S, Serra R. Trophic effects of polynucleotides and hyaluronic acid in the healing of venous ulcers of the lower limbs: a clinical study. Int Wound J. 2016 Oct;13(5):754-8. doi: 10.1111/iwj.12368. Epub 2014 Sep 16.
citation: Araco A, Araco F. Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars. Aesthet Surg J. 2021 Jun 14;41(7):NP866-NP874. doi: 10.1093/asj/sjab125.
citation: Lim TS, Liew S, Tee XJ, Chong I, Lo FJ, Ho MJ, Ong K, Cavallini M. Polynucleotides HPT for Asian Skin Regeneration and Rejuvenation. Clin Cosmet Investig Dermatol. 2024 Feb 13;17:417-431. doi: 10.2147/CCID.S437942. eCollection 2024.