An interventional study of PN30 (RDM16) in Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers and Skin Elasticity, sponsored by Mastelli S.r.l. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Mastelli S.r.l · Not applicable, Interventional, and Treatment
Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging. Injectable anti-aging products have been widely used for aesthetic improvement of the skin.
In recent years, new filler products made from High Purification Technology Polynucleotides (PN HPTTM) have been developed and are now being used in Europe. PN HPTTM has a consolidated utilization in the aesthetic field and recently, specific guidelines in their utilization have been implemented. Polynucleotides (PNs) are polymeric chains formed by purines, pyrimidines, deoxyribonucleotides, and deoxyribonucleosides that can be found in cells throughout the human body. PNs have viscoelastic properties and the capability to bind, reorganize and orientate a high concentration of water molecules, creating 3D gel that undergoes an enzymatic cleavage.
On this basis, polynucleotide-containing products act as short-time temporary fillers to produce a volumizing effect and exert a lubricant and moisturizing action, due to the high concentration of water molecules. Moreover, they maintain for a long time the moisturizing and viscoelastic effect.
A recent report which summarizes the findings and recommendations issued from the Italian Scientific Board of aesthetic physicians, supports the use of PN-HPT.
In this context, the Sponsor has developed PN30, a soft-tissue filler containing PN-HPT (at a concentration of 30 mg/ mL) as functional ingredients which help improve skin turgor and elasticity due to their moisturizing and viscoelastic properties.
PN30 is a new device with no history of marketing but based on a similar product CE marked developed and sold by the Manufacturer with less amount of PN (2%). Therefore, the aim of this pre-market, twostages, monocentric, interventional, single-arm, clinical investigation is to evaluate the safety and the performance of PN30 (RDM16) for the improvement of skin hydration. The clinical investigation is planned as an adaptative two-stages study.
The planned procedures will be the same for both stages. The primary objective/endpoint of STAGE I will be to evaluate the safety, while the primary objective/endpoint of STAGE II will be to evaluate the performance of the device.
Mastelli S.r.l is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: PN30 (RDM16)
PN30 is a viscoelastic, sterile gel, in a disposable prefilled syringe for intradermal infiltration.PN30 contains polynucleotides (3%). The polynucleotides contained in the device are substances of natural, fish-derived origin, highly purified.
Stage I - Skin examination (through evaluation of possible cutaneous reactions)
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage I - Device deficiencies monitoring
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 the investigational medical device. The rate of DD will be assessed and counted by the investigator at baseline (Visit 0), at Visit 1 and at Visit 2.
Time frame: At baseline (first injection) and 5 weeks ± 7 days from baseline (second and last injection)
Stage I - 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: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage II - Aesthetic evaluation of the skin through the change in Global Aesthetic Improvement Scale (GAIS) completed per each area treated by the Investigator
To evaluate the performance of PN30 for the aesthetic improvement of the skin after 10 weeks from the last treatment, the change in 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 V2 to baseline (pre-treatment) will be assessed. The GAIS will be completed per each area treated by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each area treated for all subjects enrolled.
Time frame: 10 weeks from the last treatment
Stage I and Stage II - Aesthetic evaluation of the skin through the change in Global Aesthetic Improvement Scale (GAIS) completed per each area treated by the Investigator
To evaluate the performance of PN30 for the aesthetic improvement of the skin at each visit, the change in 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. The GAIS will be completed per each area treated by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each area treated for all subjects enrolled.
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage I and Stage II - Evaluation the performance of PN30 on skin hydration at each visit through the MoistureMeterEpiD
The MoistureMeterEpiD (Delfin Technology, Finland) generates a high frequency (300 MHz), low power electromagnetic (EM) wave which the tissue is exposed to. The reflected EM wave is registered, and the obtained value is a dielectric constant (TDC), which is proportional to the water content of the measured tissue. The value increases with increasing water content. The dielectric constant is converted to water percentage (0-100%).
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage I and Stage II - Evaluation the performance of PN30 on skin elasticity at each visit through the ElastiMeter
The ElastiMeter (Delfin Technology, Finland) comprises a reference plate with an indenter located at the centre. As the instrument is pressed briefly against the skin, a constant deformation to the skin surface is produced without altering the skin structure. A sensor measures the force required to produce the deformation from which the instant skin elasticity can be determined. The ElastiMeter measures skin elasticity in N/m.
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage I and Stage II - Evaluation of the performance of PN30 on skin turgor at each visit through a 5-point Likert scale assessed by the Investigator
A 5-point Likert scale is a survey tool with five response options designed to measure the opinions, including two negative options, one neutral option, and two positive options.
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
Stage I and Stage II - Injection pain intensity through the Numerical Rating Scale (NRS)
The NRS consists of an 11-point scale from 0 to 10, where 0 means "no pain" and 10 represents "worst imaginable pain". The NRS can be administered verbally soon after the injection or by telephone after the injection, if anesthesia is performed. In this case, the Investigator should wait until the effect of anesthesia is resolved before asking the Subject the numerical value that best describes her/his pain intensity.
Time frame: At baseline (first injection) and 5 weeks ± 7 days from baseline (second and last injection)
Stage I and Stage II - Evaluation of the subject satisfaction through a 5-point Likert scale
To evaluate subject satisfaction with PN30, 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 2 and at End of study (Visit 3)
Time frame: 10 weeks ± 7 days after last treatment and 12 weeks ± 7 days after last treatment (End Of Study)
Started Sep 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.
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