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

NCT06821854 | Completed

• 1 other identifier: M-PN20-2024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Hydration; Skin Elasticity

Keywords

skin hydration; Polynucloetides; PN HPT; Mastelli; Plinest

Outcome Measures

Primary Outcomes (1)

• Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator

  To evaluate the performance of PN20 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.

  From enrollment to the end after 4 months from the last treatment.

Secondary Outcomes (8)

• Change in Investigator and Subject Global Aesthetic Improvement Scale (GAIS) at each visit

  From enrollment to the end after 4 months from the last treatment (at each visit)

• Performance of PN20 on the skin hydration at each visit

  From enrollment to the end after 4 months from the last treatment (at each visit)

• Performance of PN20 on skin elasticity at each visit

  From enrollment to the end after 4 months from the last treatment (at each visit)

• Performance of PN20 on skin turgor at each visit

  From enrollment to the end after 4 months from the last treatment (at each visit)

• Pain intensity after injection of PN20

  Visit 0 (Baseline), Visit 1 and Visit 2

Study Arms (1)

Treatment arm

EXPERIMENTAL

Device: PN20 (Plinest)

Interventions

PN20 (Plinest) DEVICE

PN20 (Plinest) is a single-use viscoelastic, and sterile gel for intradermal use. PN20 contains polynucleotides (20 mg/ml- 2%), water, sodium chloride, sodium phosphate and disodium phosphate. PN20 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. PN20 can also be administered by means of modern non-invasive techniques (electroporation, hydroelectrophoresis, etc.). In all these cases, thoroughly cleanse and disinfect the area to be treated before application. PN20, thanks to its versatility and manageability, can be used in any skin area; in the current clinical investigation the face, neck or décolleté will be treated.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject Informed consent form (ICF) signed;
• Female and male Subjects aged 18-70 years;
• Subjects desiring improvement of skin hydration in maximum 2 areas of the face, or 1 area of the face plus neck or décolleté;
• Healthy skin;
• Willingness to discontinue all dermatological treatment and procedures during the study;
• Willingness to follow all study procedures, including attending all site visits, tests and examinations;
• Agreeing to present at each study visit without face/neck/ décolleté cosmetics;
• Accepting to not change their habits regarding food, physical activity, face/neck/décolleté cosmetics and cleansing products;
• 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;
• Skin phototype I-IV according to Fitzpatrick's classification.

You may not qualify if:

• 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);
• Infectious or inflammatory processes near the area of intervention;
• Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;
• Presence of tendon, bone or muscular implants near the area of intervention;
• Ongoing cutaneous allergies;
• Allergy or contraindications to device components;
• Concomitant intake of anticoagulant or antiplatelet medications;
• Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
• Immune system illnesses/disease;
• Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
• Known drug and/or alcohol abuse;
• Mental incapacity that precludes adequate understanding or cooperation;
• Pregnancy or breastfeeding;

Sponsors & Collaborators

• Mastelli S.r.l: lead

Study Sites (1)

Clinica di Chirurgia plastica e ricostruttiva/Ospedale Policlinico San Martino

Genova, Italy, 16132, Italy

Location

Related Publications (5)

• 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

  BACKGROUND

• 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.

  PMID: 38371328 BACKGROUND

• 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.

  PMID: 33755110 BACKGROUND

• 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.

  PMID: 25224018 BACKGROUND

• 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.

  PMID: 32799391 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 12, 2025
• Study Start: December 9, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)