Polynucleotide-based injectable to improve skin hydration
A Pre-market, Two-stages, Monocentric, Interventional, Single-arm, Clinical Investigation to Evaluate the Safety and the Performance of PN30 (RDM16) for the Improvement of Skin Hydration
This trial will test an injectable polynucleotide product to see if it improves skin hydration and firmness in healthy adults who want better-looking skin on the face, neck, or décolleté.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mastelli S.r.l Industry-sponsored |
| Locations | 1 site (Naples, Italy) |
| Trial ID | NCT07151859 on ClinicalTrials.gov |
What this trial studies
This interventional study gives injections of a high-purity polynucleotide product (PN30 / RDM16) into a single area of the face, neck, or décolleté in healthy volunteers aged 18–70. Polynucleotides are long-chain molecules that can bind and organize water to form a viscoelastic gel intended to boost hydration and skin quality. Participants must stop other dermatologic treatments, avoid makeup and certain sun/heat exposures around visits, and return for scheduled follow-ups where hydration, elasticity, turgor, and satisfaction will be measured. The study is conducted at a single academic center in Naples, Italy under company sponsorship with protocol-driven injection and evaluation procedures.
Who should consider this trial
Good fit: Healthy men and women aged 18 to 70 with skin phototypes I–IV seeking improved hydration in a single area of the face, neck, or décolleté and willing to follow visit and treatment restrictions are ideal candidates.
Not a fit: People with active skin disease, those seeking structural facial volume correction or treatment of multiple areas, individuals outside the 18–70 age range or phototypes outside I–IV, or those unwilling to follow study restrictions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could increase skin hydration and firmness, improving radiance and patient satisfaction with a minimally invasive injectable approach.
How similar studies have performed: Polynucleotide-based fillers have been used in Europe with growing clinical experience and encouraging case-series reports, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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 1 area of the face or desiring improvement of skin hydration of 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 avoid make-up in the 12 hours following the injection treatment and to avoid any prolonged exposure to the sun, UV rays and temperatures below 0°C, as well as any sauna or hammam sessions at least until the wheals have been fully reabsorbed; 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.
Where this trial is running
Naples, Italy
- Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.