Facial WrinklesCIP-02-25NCT07881926
Evaluation of MD60002 Device for Facial Skin Aging
A study testing Device: MD60002 in people with Facial Wrinkles and Skin Aging, run by Promoitalia Group Spa at 1 site in Italy.
Trial summary
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles, Skin Aging, Skin Imperfections
- What is being tested?
- Device: MD60002
- 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
- 20 Nov 2026to 1 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 65 years. Presence of facial skin defects/wrinkles with a Lemperle Wrinkle Severity Scale (LWSS) score ≥ 1 at baseline.
- Signed written informed consent to participate in the study.
Who cannot join
- Subjects aged under 18 or over 65 years. Presence of concomitant skin diseases, active infections, or inflammation in the area to be treated.
- Known severe allergies, hypersensitivity to hyaluronic acid or any component of the investigational product, or history of anaphylactic reactions.
- History of autoimmune diseases, severe chronic/systemic pathologies, or bleeding/coagulation disorders.
- History of hypertrophic scars, keloids, or abnormal cicatrization. Recent aesthetic treatments (e.g., dermal fillers, botulinum toxin, laser, chemical peels) in the target anatomical area within the preceding months.
- Pregnant or breastfeeding women (negative pregnancy test required at screening for women of childbearing potential).
- Concomitant conditions or therapies that, in the opinion of the Investigator, could compromise subject safety or interfere with study evaluations.
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
Clinica santa maria la bruna
Torre del Greco, Napoli, 80059
Giuseppe Ferraro, +39 366 465 48 16, giuseppe.ferraro@unimol.it
About this study
Official title: Performance and Safety Evaluation of the MD60002 Device in the Treatment of Skin Imperfections Due to Aging
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial aging.
A total of 43 adult subjects presenting with facial wrinkles (Lemperle Wrinkle Severity Scale score ≥ 1) will be enrolled. Participants will receive intradermal injections of MD60002 according to a standardized protocol.
The primary endpoint is the evaluation of aesthetic improvement measured by the change in the Lemperle Wrinkle Severity Scale (LWSS) score from baseline to the 30-day follow-up visit. Secondary endpoints include patient-reported subjective satisfaction evaluated via the Global Aesthetic Improvement Scale (GAIS), alongside comprehensive safety, tolerability, and device deficiency monitoring in accordance with ISO 14155 guidelines.
Read the detailed description
This clinical investigation is structured as a prospective, single-center, non-controlled, single-arm study designed to evaluate the performance and safety of the investigational Class III medical device MD60002. MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The primary mechanism of action relies on the hydrophilic properties of polynucleotides, which complex with water molecules to provide a natural volumizing and hydrating effect within the dermo-epidermal tissue, thereby improving skin tone, elasticity, and reducing aesthetic skin defects caused by physiological aging (such as wrinkles).
A total of 43 subjects will be enrolled at a single clinical site (Casa di Cura Santa Maria La Bruna, Torre del Greco, Italy) under the supervision of the Principal Investigator, Prof. Giuseppe Ferraro. The study population comprises adult subjects presenting with facial skin defects and wrinkles characterized by a baseline Lemperle Wrinkle Severity Scale (LWSS) score of 1 or greater.
Study Procedures and Schedule:
- Screening and Baseline (Visita 1): Assessment of inclusion and exclusion criteria, medical history review, pregnancy testing for women of childbearing potential, verification of concomitant medications, clinical evaluation of facial aging, baseline clinical photography, and assignment of the baseline LWSS score.
- Treatment (Visita 2): Administration of intradermal injections of the MD60002 device (up to a maximum of 2 ml depending on the defect) into the targeted facial areas using sterile techniques and the provided 30G 1/2 needles.
- Intermediate Treatment Visit (Visita 3): Conducted at 21 days (±6 days) post-baseline, involving a treatment session and safety checks.
- End of Study / Follow-up Visit (Visita 4): Conducted at 30 days (±7 days) following the final treatment session. This visit includes clinical evaluation of performance via LWSS scoring, patient-reported subjective satisfaction assessment using the Global Aesthetic Improvement Scale (GAIS), clinical photography, and thorough monitoring for any adverse events (AEs), serious adverse events (SAEs), or device deficiencies.
Endpoints and Statistical Analysis:
- Primary Endpoint: Evaluation of aesthetic performance measured by the change in the LWSS score between baseline and the 30-day follow-up visit. The primary objective is considered achieved if the median of individual LWSS score changes is ≤ -1 point, evaluated using a two-tailed Wilcoxon signed-rank test at a significance level of alpha = 0.05.
- Secondary Endpoint: Evaluation of patient-reported subjective satisfaction using the 5-point GAIS questionnaire at the final follow-up visit. The secondary objective is met if at least 70% of subjects report a GAIS score of 3 or better ("improved", "much improved", or "very much improved/excellent result").
- Safety Endpoints: Assessment of local tolerability, frequency and severity of expected and unexpected adverse events (AEs, ADEs, SAEs, SADEs), and device deficiencies in strict accordance with ISO 14155 guidelines.
- Conditions
- Facial Wrinkles, Skin Aging, Skin Imperfections
- Being tested
- Device: MD60002
- Keywords
- MD60002, Polynucleotides, Dermal filler, Skin aging, Facial wrinkles, Aesthetic medicine, Intradermal gel, Lemperle Wrinkle Severity Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: MD60002Device
MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The device is supplied in a pre-filled 2 ml syringe, packaged in a blister along with sterile 30G 1/2" needles. Participants will receive slow intradermal injections of MD60002 into targeted facial areas (up to a maximum volume of 2 ml per session depending on the defect) using strict aseptic techniques and following the sponsor's provided training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: MD60002 Treatment Group | Experimental | Experimental Arm: The participants in this single-arm study will receive intradermal injections of the investigational medical device MD60002 (composed of 3% polynucleotides) for the treatment of facial skin aging and wrinkles, administered according to a standardized protocol across designated treatment sessions. Receives: Device: Device: MD60002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Lemperle Wrinkle Assessment Scale (LWSS) Score
Change in wrinkle severity evaluated using the Lemperle Wrinkle Assessment Scale (LWSS). The scale ranges from 0 (no wrinkles) to 5 (very deep wrinkles, redundant fold). A lower score indicates greater aesthetic improvement.
Measured: Baseline (Day 0) and 30 (± 7) days after the final treatment visit
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Device Defect Logs
Assessment of device safety evaluated through the recording, incidence, severity, and causal relationship of local and systemic adverse events, local injection site reactions (e.g., erythema, edema, pain), and device defects throughout the study duration.
Measured: From baseline (Day 0) up to 30 (± 7) days post-treatment
Investigator Global Aesthetic Improvement Scale (GAIS) Rating
Assessment of overall aesthetic improvement rated by the Investigator using the GAIS 5-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, 5 = Worse).
Measured: 30 (± 7) days after the final treatment visit
Secondary outcomes (2)
Subject Satisfaction Score Measured by Global Aesthetic Improvement Scale (GAIS)
Subject-assessed aesthetic improvement using the Global Aesthetic Improvement Scale (GAIS), a 5-point ordinal scale (1 = Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, 5 = Worse). Success is defined as at least 70% of subjects reporting a score of 3 or lower.
Measured: 30 (± 7) days after the final treatment visit (Visit 4)
Incidence and Severity of Adverse Events (AEs) and Device Deficiencies
Incidence, frequency, and severity of treatment-emergent adverse events (AEs), serious adverse events (SAEs), device-related adverse effects (ADEs/SADEs), and device deficiencies recorded throughout the study.
Measured: From baseline (Day 0) through 30 (± 7) days post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial WrinklesStudies 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
- Promoitalia Group Spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881926
- Sponsor's protocol ID
- CIP-02-25
- Acronym
- CIP-02-25
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Kim J, Lee YN, Choi S, Lee YI, Suk J, Lee JH. The efficacy of intradermal hyaluronic acid filler as a skin quality booster: A prospective, single-center, single-arm pilot study. J Cosmet Dermatol. 2024 Feb;23(2):409-416. doi: 10.1111/jocd.15944. Epub 2023 Sep 13.
PubMed 37705328
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Evaluation of the MD60002 Device in the Treatment of Skin Imperfections Due to Aging
- ClinicalTrials.gov ID
- NCT07881926
- Acronym / sponsor ID
- CIP-02-25 / CIP-02-25
- Conditions
- Facial Wrinkles, Skin Aging, Skin Imperfections
- Keywords
- MD60002, Polynucleotides, Dermal filler, Skin aging, Facial wrinkles, Aesthetic medicine, Intradermal gel, Lemperle Wrinkle Severity Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Promoitalia Group SpaIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial aging.
A total of 43 adult subjects presenting with facial wrinkles (Lemperle Wrinkle Severity Scale score ≥ 1) will be enrolled. Participants will receive intradermal injections of MD60002 according to a standardized protocol.
The primary endpoint is the evaluation of aesthetic improvement measured by the change in the Lemperle Wrinkle Severity Scale (LWSS) score from baseline to the 30-day follow-up visit. Secondary endpoints include patient-reported subjective satisfaction evaluated via the Global Aesthetic Improvement Scale (GAIS), alongside comprehensive safety, tolerability, and device deficiency monitoring in accordance with ISO 14155 guidelines.
Detailed description
This clinical investigation is structured as a prospective, single-center, non-controlled, single-arm study designed to evaluate the performance and safety of the investigational Class III medical device MD60002. MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The primary mechanism of action relies on the hydrophilic properties of polynucleotides, which complex with water molecules to provide a natural volumizing and hydrating effect within the dermo-epidermal tissue, thereby improving skin tone, elasticity, and reducing aesthetic skin defects caused by physiological aging (such as wrinkles).
A total of 43 subjects will be enrolled at a single clinical site (Casa di Cura Santa Maria La Bruna, Torre del Greco, Italy) under the supervision of the Principal Investigator, Prof. Giuseppe Ferraro. The study population comprises adult subjects presenting with facial skin defects and wrinkles characterized by a baseline Lemperle Wrinkle Severity Scale (LWSS) score of 1 or greater.
Study Procedures and Schedule:
- Screening and Baseline (Visita 1): Assessment of inclusion and exclusion criteria, medical history review, pregnancy testing for women of childbearing potential, verification of concomitant medications, clinical evaluation of facial aging, baseline clinical photography, and assignment of the baseline LWSS score.
- Treatment (Visita 2): Administration of intradermal injections of the MD60002 device (up to a maximum of 2 ml depending on the defect) into the targeted facial areas using sterile techniques and the provided 30G 1/2 needles.
- Intermediate Treatment Visit (Visita 3): Conducted at 21 days (±6 days) post-baseline, involving a treatment session and safety checks.
- End of Study / Follow-up Visit (Visita 4): Conducted at 30 days (±7 days) following the final treatment session. This visit includes clinical evaluation of performance via LWSS scoring, patient-reported subjective satisfaction assessment using the Global Aesthetic Improvement Scale (GAIS), clinical photography, and thorough monitoring for any adverse events (AEs), serious adverse events (SAEs), or device deficiencies.
Endpoints and Statistical Analysis:
- Primary Endpoint: Evaluation of aesthetic performance measured by the change in the LWSS score between baseline and the 30-day follow-up visit. The primary objective is considered achieved if the median of individual LWSS score changes is ≤ -1 point, evaluated using a two-tailed Wilcoxon signed-rank test at a significance level of alpha = 0.05.
- Secondary Endpoint: Evaluation of patient-reported subjective satisfaction using the 5-point GAIS questionnaire at the final follow-up visit. The secondary objective is met if at least 70% of subjects report a GAIS score of 3 or better ("improved", "much improved", or "very much improved/excellent result").
- Safety Endpoints: Assessment of local tolerability, frequency and severity of expected and unexpected adverse events (AEs, ADEs, SAEs, SADEs), and device deficiencies in strict accordance with ISO 14155 guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: MD60002 Treatment Group | Experimental | Device: Device: MD60002Experimental Arm: The participants in this single-arm study will receive intradermal injections of the investigational medical device MD60002 (composed of 3% polynucleotides) for the treatment of facial skin aging and wrinkles, administered according to a standardized protocol across designated treatment sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 18 and 65 years. Presence of facial skin defects/wrinkles with a Lemperle Wrinkle Severity Scale (LWSS) score ≥ 1 at baseline.
- Signed written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Subjects aged under 18 or over 65 years. Presence of concomitant skin diseases, active infections, or inflammation in the area to be treated.
- Known severe allergies, hypersensitivity to hyaluronic acid or any component of the investigational product, or history of anaphylactic reactions.
- History of autoimmune diseases, severe chronic/systemic pathologies, or bleeding/coagulation disorders.
- History of hypertrophic scars, keloids, or abnormal cicatrization. Recent aesthetic treatments (e.g., dermal fillers, botulinum toxin, laser, chemical peels) in the target anatomical area within the preceding months.
- Pregnant or breastfeeding women (negative pregnancy test required at screening for women of childbearing potential).
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 |
|---|---|---|
| Device: MD60002MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The device is supplied in a pre-filled 2 ml syringe, packaged in a blister along with sterile 30G 1/2" needles. Participants will receive slow intradermal injections of MD60002 into targeted facial areas (up to a maximum volume of 2 ml per session depending on the defect) using strict aseptic techniques and following the sponsor's provided training. | Device | Experimental: MD60002 Treatment Group |
Primary outcome
Change from Baseline in Lemperle Wrinkle Assessment Scale (LWSS) Score
Time frame: Baseline (Day 0) and 30 (± 7) days after the final treatment visit
Change in wrinkle severity evaluated using the Lemperle Wrinkle Assessment Scale (LWSS). The scale ranges from 0 (no wrinkles) to 5 (very deep wrinkles, redundant fold). A lower score indicates greater aesthetic improvement.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Device Defect Logs
Time frame: From baseline (Day 0) up to 30 (± 7) days post-treatment
Assessment of device safety evaluated through the recording, incidence, severity, and causal relationship of local and systemic adverse events, local injection site reactions (e.g., erythema, edema, pain), and device defects throughout the study duration.
Investigator Global Aesthetic Improvement Scale (GAIS) Rating
Time frame: 30 (± 7) days after the final treatment visit
Assessment of overall aesthetic improvement rated by the Investigator using the GAIS 5-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Improved, 4 = No Change, 5 = Worse).
2 secondary outcomes
Subject Satisfaction Score Measured by Global Aesthetic Improvement Scale (GAIS)
Time frame: 30 (± 7) days after the final treatment visit (Visit 4)
Incidence and Severity of Adverse Events (AEs) and Device Deficiencies
Time frame: From baseline (Day 0) through 30 (± 7) days post-treatment follow-up
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 20 Oct 2026.
- Background: PubMed 37705328Lee JH, Kim J, Lee YN, Choi S, Lee YI, Suk J, Lee JH. The efficacy of intradermal hyaluronic acid filler as a skin quality booster: A prospective, single-center, single-arm pilot study. J Cosmet Dermatol. 2024 Feb;23(2):409-416. doi: 10.1111/jocd.15944. Epub 2023 Sep 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: MD60002 in people with Facial Wrinkles and Skin Aging, run by Promoitalia Group Spa 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Oct 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?
Contact Grazia Iannacci (+39 331 591 3106, Executive.assistant@webpromoitalia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Lemperle Wrinkle Assessment Scale (LWSS) Score (time frame: Baseline (Day 0) and 30 (± 7) days after the final treatment visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07881926, which also lists 1 linked publication.
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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.