Actively Recruiting
A Pre-market, Two-stages, Monocentric, Interventional, Single-arm Clinical Investigation to Evaluate the Safety and Performance of PN30 (RDM16) for Skin Hydration Improvement
Led by Mastelli S.r.l · Updated on 2026-02-03
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mastelli S.r.l
Lead Sponsor
1
1Med
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new polynucleotide-based soft-tissue filler called PN30 (RDM16) designed to improve skin hydration, elasticity, and turgor. This clinical investigation is a pre-market, two-stage, single-arm trial to evaluate both the safety and performance of PN30, a product developed using High Purification Technology Polynucleotides (PN HPTTM). These polynucleotides are natural substances with moisturizing and viscoelastic properties, intended to act as temporary fillers that enhance skin appearance by increasing hydration and firmness. The study involves administering PN30 via intradermal injections in a single treatment arm. PN30 is provided as a sterile, viscoelastic gel in prefilled syringes, containing 3% polynucleotides derived from natural fish origin. The investigation is adaptive with two stages: Stage I focuses on safety assessment through skin examination and monitoring of device-related events, while Stage II evaluates the product's aesthetic performance using various skin assessment tools. Participants will undergo injections and attend scheduled visits over approximately 12 weeks, during which researchers will assess skin reactions, hydration, elasticity, turgor, and patient satisfaction. Tools used include the Global Aesthetic Improvement Scale (GAIS), MoistureMeterEpiD, ElastiMeter, and pain rating scales. Safety monitoring will continue through adverse event tracking and device deficiency checks. Participants must follow study guidelines regarding cosmetic use and sun exposure throughout the trial.
CONDITIONS
Brief Title
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Female and male subjects aged 18 to 70 years
- Desire to improve skin hydration in one area of the face, neck, or décolleté
- Healthy skin
- Willingness to stop all dermatological treatments and procedures during the study
- Agreement to attend all study visits, tests, and examinations
- Agreement to attend visits without face, neck, or décolleté cosmetics
- Acceptance to maintain regular habits regarding food, physical activity, cosmetics, and cleansing products
- Willingness to avoid make-up for 12 hours after injection and avoid sun exposure, UV rays, extreme temperatures, sauna, or hammam until skin reaction resolves
- Skin phototype I to IV according to Fitzpatrick's classification
You will not qualify if you...
- Presence of skin conditions such as rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne, or cancer under treatment
- Infectious or inflammatory processes near the treatment area
- Cutaneous disease on the tested area like malformations or recurrent facial/labial herpes
- Tendon, bone, or muscular implants near the treatment area
- Ongoing cutaneous allergies
- Allergy or contraindication to device components
- Use of anticoagulant or antiplatelet medications
- Lack of required washout period from topical corticosteroids, antibiotics, or other specified skin treatments
- Immune system diseases
- Uncontrolled diabetes or systemic diseases
- Recent treatment with drugs affecting blood fluidity within 5 days prior to inclusion
- Known drug or alcohol abuse
- Mental incapacity preventing understanding or cooperation
- Previous permanent or temporary aesthetic treatments on the treated area within 6 months
- Pregnancy or breastfeeding
- Participation in another investigational study within 1 month prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks ± 7 days
Participants receive injections of the PN30 device to improve skin hydration in one area of the face, neck, or décolleté.
2 visits (in-person) for injections
Duration - Up to 12 weeks ± 7 days after last treatment
Participants are monitored for skin reactions, device performance, and aesthetic improvements after the last treatment.
Multiple visits for assessments up to 12 weeks after last injection
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy, Italy, 80131
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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