Skin HydrationNCT06821854
Efficacy and Safety of PN20 (Plinest) for the Improvement of Skin Hydration
A study testing PN20 (Plinest) in people with Skin Hydration and Skin Elasticity, run by Mastelli S.r.l at 1 site in Italy.
Trial summary
This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN20 (PLINEST) for the improvement of skin hydration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Hydration, Skin Elasticity
- What is being tested?
- PN20 (Plinest)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- 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 2 areas of the face, or 1 area of the face plus 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 minimize exposure of the treated area to too much sunlight or extreme cold, at least until the papules have completely subsided;
- 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;
Show all 16Show fewer
- 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.
Italy1 site
Clinica di Chirurgia plastica e ricostruttiva/Ospedale Policlinico San Martino
Genova, Italy, 16132
About this study
Official title: A Post-market, Monocentric, Interventional, Single-arm, Confirmative Clinical Investigation to Evaluate the Performance and the Safety of PN20 (Plinest) for the Improvement of Skin Hydration
This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN20 (PLINEST) for the improvement of skin hydration.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF.
Read more
For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart:
- V0 (Screening/baseline): Day 0, when the first IP injection will be performed;
- V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed;
- V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT);
- V3: maximum 4 months from V0 and 2 months after the last IP injection (V2);
- V4: maximum 6 months form V0 and 4 months after the last IP injection (V2).
At V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject.
At V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN20 in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté, making sure that at least 14 areas for face, neck and décolleté will be reached.
Local anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject.
Performance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per each area treated) at each visit.
Skin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.
Skin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.
At V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Subject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).
Safety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.
- Conditions
- Skin Hydration, Skin Elasticity
- Being tested
- PN20 (Plinest)
- Keywords
- skin hydration, Polynucloetides, PN HPT, Mastelli, Plinest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN20 (Plinest)Device
PN20 (Plinest) is a single-use viscoelastic, and sterile gel for intradermal use. PN20 contains polynucleotides (20 mg/ml- 2%), water, sodium chloride, sodium phosphate and disodium phosphate.
PN20 is administered using a fine needle (usually 30 G) by injecting the solution into the dermis. Depending on the medical assessment, different injection techniques, such as linear threading, serial punctures, crosslinked, radial fanning or mixed, can be used. The injection site must consist of healthy skin. PN20 can also be administered by means of modern non-invasive techniques (electroporation, hydroelectrophoresis, etc.). In all these cases, thoroughly cleanse and disinfect the area to be treated before application.
PN20, thanks to its versatility and manageability, can be used in any skin area; in the current clinical investigation the face, neck or décolleté will be treated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: PN20 (Plinest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator
To evaluate the performance of PN20 on the aesthetic appearance of the skin 4 months after the last treatment, the change in the 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 V4 to baseline (pre-treatment), will be assessed. The GAIS will be completed by the Investigator.
The pre-treatment GAIS score (at baseline/V0) will be "4" for each treated area for all enrolled subjects.
Measured: From enrollment to the end after 4 months from the last treatment.
Secondary outcomes (8)
Change in Investigator and Subject Global Aesthetic Improvement Scale (GAIS) at each visit
To evaluate the performance of PN20 on the aesthetic appearance of the skin, the change in the 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 at each visit. The GAIS will be completed independently by the Investigator and the Subject.
Measured: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on the skin hydration at each visit
To evaluate the performance of PN20 on skin hydration at each visit, the MoistureMeterEpiD, which displays percentage water content (0 - 100 %), will be used by the Investigator.
Measured: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on skin elasticity at each visit
To evaluate the performance of PN20 on skin elasticity at each visit, the ElastiMeter, which measures skin elasticity in N/m, will be used by the Investigator at each visit.
Measured: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on skin turgor at each visit
To evaluate the performance of PN20 on skin turgor at each visit, a 5-Likert scale (1 - Very poor, 2 - Poor, 3 - Good, 4 - Very good, 5 - Excellent) will be used by the Investigator at each visit.
Measured: From enrollment to the end after 4 months from the last treatment (at each visit)
Pain intensity after injection of PN20
To evaluate pain intensity after injection of PN20, a Numerical Rating Scale (NRS), a 0 to 10 scale indicating the degree of pain the patient experienced (0 - No Pain, 5 - Moderate Pain, 10 - Worst possible Pain), will be used at Visit 0 (Baseline), Visit 1 and Visit 2.
Measured: Visit 0 (Baseline), Visit 1 and Visit 2
Subject satisfaction with PN20
To evaluate subject satisfaction with PN20, 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 3 and at End of study (Visit 4)
Measured: Visit 3 and at End of study (Visit 4)
Device deficiencies
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: Baseline (Visit 0), Visit 1, and Visit 2
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.
Measured: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Dec 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin HydrationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mastelli S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821854
- Sponsor's protocol ID
- M-PN20-2024
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
E. Bartoletti et al., "PN HPTTM and Striae Albae-Exploratory Interim Analysis of a Randomised Prospective Study," Surgical Research, vol. 5, no. 3, Sep. 2023, doi: 10.33425/2689-1093.1057
Lim TS, Liew S, Tee XJ, Chong I, Lo FJ, Ho MJ, Ong K, Cavallini M. Polynucleotides HPT for Asian Skin Regeneration and Rejuvenation. Clin Cosmet Investig Dermatol. 2024 Feb 13;17:417-431. doi: 10.2147/CCID.S437942. eCollection 2024.
PubMed 38371328Araco A, Araco F. Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars. Aesthet Surg J. 2021 Jun 14;41(7):NP866-NP874. doi: 10.1093/asj/sjab125.
PubMed 33755110De Caridi G, Massara M, Acri I, Zavettieri S, Grande R, Butrico L, de Franciscis S, Serra R. Trophic effects of polynucleotides and hyaluronic acid in the healing of venous ulcers of the lower limbs: a clinical study. Int Wound J. 2016 Oct;13(5):754-8. doi: 10.1111/iwj.12368. Epub 2014 Sep 16.
PubMed 25224018Cavallini M, Bartoletti E, Maioli L, Massirone A, Pia Palmieri I, Papagni M, Priori M, Trocchi G; As Members of The Polynucleotides HPT Priming Board, Collegio Italiano delle Societa Scientifiche di Medicina Estetica (Italian College of the Aesthetic Medicine Scientific Societies) - SIME, AGORA, SIES. Consensus report on the use of PN-HPT (polynucleotides highly purified technology) in aesthetic medicine. J Cosmet Dermatol. 2021 Mar;20(3):922-928. doi: 10.1111/jocd.13679. Epub 2020 Sep 21.
PubMed 32799391
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Monocentric, Interventional, Single-arm, Confirmative Clinical Investigation to Evaluate the Performance and the Safety of PN20 (Plinest) for the Improvement of Skin Hydration
- ClinicalTrials.gov ID
- NCT06821854
- Acronym / sponsor ID
- M-PN20-2024
- Conditions
- Skin Hydration, Skin Elasticity
- Keywords
- skin hydration, Polynucloetides, PN HPT, Mastelli, Plinest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mastelli S.r.lIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 12 Feb 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.
This is a post-market, monocentric, interventional, single-arm, confirmative clinical investigation to evaluate the performance and the safety of PN20 (PLINEST) for the improvement of skin hydration.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening/baseline phase during which the baseline tests will be conducted. The Subject can be treated immediately after signing the ICF.
For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart:
- V0 (Screening/baseline): Day 0, when the first IP injection will be performed;
- V1: 2 weeks ± 7 days from V0, when the second IP injection will be performed;
- V2: 2 weeks ± 7 days from V1, when the third IP injection will be performed (End Of Treatment/EOT);
- V3: maximum 4 months from V0 and 2 months after the last IP injection (V2);
- V4: maximum 6 months form V0 and 4 months after the last IP injection (V2).
At V0, the Investigator will collect demographic data (e.g., gender, age, skin phototype according to Fitzpatrick's classification), medical history (e.g., history of autoimmune disease, diabetes, etc.), drug allergy history of the enrolled Subject.
At V0, V1, and V2 according to the instructions for use (IFU), the enrolled Subjects will be treated with PN20 in maximum 2 areas of the face, or 1 area of the face plus neck/décolleté, making sure that at least 14 areas for face, neck and décolleté will be reached.
Local anesthetics containing lidocaine may be used in order to guarantee the necessary comfort to the Subject.
Performance will be evaluated by the Investigator using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be independently completed by the Investigator and the Subject. Photographs with a 2D camera will be taken at each visit. Skin hydration will be assessed by using the MoistureMeterEpiD (at least three measurements will be obtained per each area treated) at each visit.
Skin elasticity will be evaluated using the ElastiMeter (at least three measurements will be obtained per each area treated) at each visit.
Skin turgor will be assessed by the Investigator using a 5-Likert scale at each visit.
At V0, V1 and V2 after injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Subject satisfaction with treatment will be evaluated with a 5-point Likert Scale at V3 and EOS visit (V4).
Safety will include evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.
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: PN20 (Plinest) |
Who may qualify
- Ages
- 18 years and older
- 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 2 areas of the face, or 1 area of the face plus 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 |
|---|---|---|
| PN20 (Plinest)PN20 (Plinest) is a single-use viscoelastic, and sterile gel for intradermal use. PN20 contains polynucleotides (20 mg/ml- 2%), water, sodium chloride, sodium phosphate and disodium phosphate. PN20 is administered using a fine needle (usually 30 G) by injecting the solution into the dermis. Depending on the medical assessment, different injection techniques, such as linear threading, serial punctures, crosslinked, radial fanning or mixed, can be used. The injection site must consist of healthy skin. PN20 can also be administered by means of modern non-invasive techniques (electroporation, hydroelectrophoresis, etc.). In all these cases, thoroughly cleanse and disinfect the area to be treated before application. PN20, thanks to its versatility and manageability, can be used in any skin area; in the current clinical investigation the face, neck or décolleté will be treated. | Device | Treatment arm |
Primary outcome
Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator
Time frame: From enrollment to the end after 4 months from the last treatment.
To evaluate the performance of PN20 on the aesthetic appearance of the skin 4 months after the last treatment, the change in the 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 V4 to baseline (pre-treatment), will be assessed. The GAIS will be completed by the Investigator. The pre-treatment GAIS score (at baseline/V0) will be "4" for each treated area for all enrolled subjects.
8 secondary outcomes
Change in Investigator and Subject Global Aesthetic Improvement Scale (GAIS) at each visit
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on the skin hydration at each visit
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on skin elasticity at each visit
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Performance of PN20 on skin turgor at each visit
Time frame: From enrollment to the end after 4 months from the last treatment (at each visit)
Pain intensity after injection of PN20
Time frame: Visit 0 (Baseline), Visit 1 and Visit 2
Subject satisfaction with PN20
Time frame: Visit 3 and at End of study (Visit 4)
Device deficiencies
Time frame: Baseline (Visit 0), Visit 1, and Visit 2
Adverse events, serious adverse events and concomitant medications monitoring
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Results publicationE. Bartoletti et al., "PN HPTTM and Striae Albae-Exploratory Interim Analysis of a Randomised Prospective Study," Surgical Research, vol. 5, no. 3, Sep. 2023, doi: 10.33425/2689-1093.1057
- Results publication: PubMed 38371328Lim TS, Liew S, Tee XJ, Chong I, Lo FJ, Ho MJ, Ong K, Cavallini M. Polynucleotides HPT for Asian Skin Regeneration and Rejuvenation. Clin Cosmet Investig Dermatol. 2024 Feb 13;17:417-431. doi: 10.2147/CCID.S437942. eCollection 2024.
- Results publication: PubMed 33755110Araco A, Araco F. Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars. Aesthet Surg J. 2021 Jun 14;41(7):NP866-NP874. doi: 10.1093/asj/sjab125.
- Results publication: PubMed 25224018De Caridi G, Massara M, Acri I, Zavettieri S, Grande R, Butrico L, de Franciscis S, Serra R. Trophic effects of polynucleotides and hyaluronic acid in the healing of venous ulcers of the lower limbs: a clinical study. Int Wound J. 2016 Oct;13(5):754-8. doi: 10.1111/iwj.12368. Epub 2014 Sep 16.
- Results publication: PubMed 32799391Cavallini M, Bartoletti E, Maioli L, Massirone A, Pia Palmieri I, Papagni M, Priori M, Trocchi G; As Members of The Polynucleotides HPT Priming Board, Collegio Italiano delle Societa Scientifiche di Medicina Estetica (Italian College of the Aesthetic Medicine Scientific Societies) - SIME, AGORA, SIES. Consensus report on the use of PN-HPT (polynucleotides highly purified technology) in aesthetic medicine. J Cosmet Dermatol. 2021 Mar;20(3):922-928. doi: 10.1111/jocd.13679. Epub 2020 Sep 21.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PN20 (Plinest) in people with Skin Hydration and Skin Elasticity, 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: finished, as of the sponsor's last update on 16 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Aesthetic Improvement Scale (GAIS) from V4 to baseline completed by Investigator (time frame: From enrollment to the end after 4 months from the last treatment.). 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 NCT06821854, which also lists 5 linked publications.
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 16 Jun 2026.