Aesthetic Improvement of the SkinNCT07151859
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
A study testing PN30 (RDM16) in people with Aesthetic Improvement of the Skin and Skin Hydration in Healthy Volunteers, run by Mastelli S.r.l at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity
- What is being tested?
- PN30 (RDM16)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject Informed consent form (ICF) signed;
- Female and male Subjects aged 18-70 years;
- Subjects desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of 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;
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- 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 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;
- Skin phototype I-IV according to Fitzpatrick's classification.
Who cannot join
- 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;
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- 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);
- 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;
- Known drug and/or alcohol abuse;
- Mental incapacity that precludes adequate understanding or cooperation;
- 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;
- Pregnancy or breastfeeding;
- Participation in another investigational study within 1 month prior to study inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy, 80131
SEGRETERIA SCIENTIFICA, +39 0817462596, segreteriafedericoii@comitatoeticocampania3.it
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity, Skin Turgor, Subject Satisfaction
- Being tested
- PN30 (RDM16)
- Keywords
- aesthetic, Polynucleotides, PN HPT, skin, skin quality, skin elasticity, skin turgor, skin hydration, face, neck, décolleté
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN30 (RDM16)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: PN30 (RDM16) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I - Skin examination (through evaluation of possible cutaneous reactions)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks from the last treatment
Secondary outcomes (6)
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.
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 10 weeks ± 7 days after last treatment and 12 weeks ± 7 days after last treatment (End Of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start18 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic Improvement of the SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mastelli S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151859
- Sponsor's protocol ID
- M-PN30-2024
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07151859
- Acronym / sponsor ID
- M-PN30-2024
- Conditions
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity, Skin Turgor, Subject Satisfaction
- Keywords
- aesthetic, Polynucleotides, PN HPT, skin, skin quality, skin elasticity, skin turgor, skin hydration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Mastelli S.r.lIndustry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: PN30 (RDM16) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject Informed consent form (ICF) signed;
- Female and male Subjects aged 18-70 years;
- Subjects desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.
- Healthy skin;
- Willingness to discontinue all dermatological treatment and procedures during the study;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment arm |
Primary outcome
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
Time frame: At baseline (first injection) and 5 weeks ± 7 days from baseline (second and last injection)
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.
Stage I - Adverse events, serious adverse events and concomitant medications monitoring.
Time frame: From enrollment to the end of study at 12 weeks ± 7 days after last treatment
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.
Stage II - Aesthetic evaluation of the skin through the change in Global Aesthetic Improvement Scale (GAIS) completed per each area treated by the Investigator
Time frame: 10 weeks from the last treatment
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.
6 secondary outcomes
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
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
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
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
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)
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
Time frame: 10 weeks ± 7 days after last treatment and 12 weeks ± 7 days after last treatment (End Of Study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PN30 (RDM16) in people with Aesthetic Improvement of the Skin and Skin Hydration in Healthy Volunteers, run by Mastelli S.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.