Skin LaxityJuläineNCT07637188
PLLA-LASYNPRO™ Injections for Skin Laxity Treatment
A study testing PLLA Injection in people with Skin Laxity, run by Nordberg Medical Italy srl at 1 site in Italy.
Trial summary
This single-center, open-label, intra-subject controlled proof-of-concept clinical study will evaluate the histological and clinical effects of Poly-L-lactic Acid (PLLA) LASYNPRO™ (Juläine) injections for treatment of skin laxity in patients requiring post-bariatric surgery. Fifteen participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Skin Laxity
- What is being tested?
- PLLA Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2026to Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged ≤ 60 years
- Previous bariatric surgery (one anastomosis gastric bypass)
- Stable weight for at least 6 months prior to baseline
- Post-weight loss skin laxity and ptosis requiring surgery
- ΔBMI ≥ 7 defined as the change in BMI from scheduled bariatric surgery to baseline
- BMI ≤ 30
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- Pittsburgh scale rating ≥10
- Ability to give written informed consent
- Willing to participate in the study and attending the visits
Who cannot join
- Skin infection or skin inflammation status
- Acute or chronic skin disease
- ΔBMI < 7 defined as the change in BMI from scheduled bariatric surgery to baseline
- BMI > 30
- Male or female aged 60 > years
- Pregnancy and lactating; if a female is of childbearing potential, she should have a negative pregnancy test and should use a highly effective method to avoid pregnancy for the duration of the trial
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- Any clinically significant findings, as determined by the investigator, from laboratory tests and individual patient's medical history, that may contraindicate post-bariatric surgery for the patient
- History of allergies to any of the constituents of the product
- Haemorrhagic disease or under anticoagulant therapy
- Have a known history of or susceptibility to keloid formation or hypertrophic scarring
- Immune deficiencies
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 Ospedaliero Universitaria Senese
Siena
R.Cuomo, roberto.cuomo2@unisi.it
About this study
Official title: Evaluation of Histological Outcomes Following Poly-L-lactic Acid (PLLA) LASYNPRO™ Injections for Skin Laxity Treatment in Patients Requiring Post Bariatric Surgery: A Proof-of-Concept Clinical Study
This single-center, open-label, intra-subject controlled proof-of-concept clinical study will evaluate the histological and clinical effects of Poly-L-lactic Acid (PLLA) LASYNPRO™ (Juläine) injections for treatment of skin laxity in patients requiring post-bariatric surgery. Fifteen participants will be enrolled. Each participant will serve as his or her own control, with one thigh treated with PLLA LASYNPRO™ and the contralateral thigh left untreated.
Participants will receive 3 injections in the treated thigh over approximately 3 months, followed by planned post-bariatric plastic surgery at 3, 6, or 9 months after the last injection, depending on assigned group. During surgery, tissue samples from treated and untreated areas will be collected for histological evaluation. A follow-up visit will occur approximately 30 days after surgery.
The primary endpoint is comparison of collagen type I and collagen type III between treated and untreated areas. Secondary endpoints include histological comparison of elastic fibers, stromal cell populations, inflammatory biomarkers, cell proliferation markers, and assessment of stretch marks, as well as safety. An exploratory endpoint is assessment of post-operative scar healing.
- Conditions
- Skin Laxity
- Being tested
- PLLA Injection
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLLA InjectionDevice
Three injections
| Study group | Role | What they receive |
|---|---|---|
| Treated thigh | Experimental | PLLA injection Receives: Device: PLLA Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the histological effects of PLLA LASYNPRO™ JULÄINE injections in the cutaneous tissue of patients requiring post-bariatric surgery for skin laxity.
Comparison of collagen type I and type III between treated and not treated areas
Measured: Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)
Secondary outcomes (11)
Density of elastic fibres in JULÄINE treated vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of: Density of elastic fibres (Massons's trichrome staining and Van Gieson staining for elastic fibres).
Unit of Measure: % stained Area
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Percentage of fragmented elastic fibres (elastolysis) in JULÄINE treated vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
-Presence and percentage of fragmented elastic fibres (elastolysis): quantitative count of the area occupied by elastic fibres as well as the number of intact and fragmented fibres.
Unit of Measure:% of Total Fibers
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Stromal cell population in JULÄINE treated vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
-Stromal cell population evaluated as the percentage of single cell populations/mm2.
Unit of Measure: percentage of single cell populations per mm².
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of Demodex in JULÄINE treated vs non-treated areas
Presence of etiological agents related to inflammation (PAS: Demodex) Unit of Measure: Positive/negative
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of etiological agents of inflammation (CD68, CD3, CD20) in JULÄINE treated vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
-Presence of following antibodies: CD68 (macrophages); CD3 and CD20 (lymphocytes).
Unit of Measure: Cells count/ mm2
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of etiological agents of inflammation ( Vimentin, CD34,) in JULÄINE treated vs non-treated areas
-Presence of the following antibodies: Vimentin and CD34 (stroma) Unit of Measure: %
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of Ki-67 as marker of cell proliferation in JULÄINE-treated and non-treated areas
Presence of Ki-67 as marker of cell proliferation. Unit of measure: percentage of Ki-67-positive cells (%)
Measured: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of fibrilline, elastine, emilin-1 and collagen type IV and VII in JULÄINE vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
- presence of fibrilline
- presence of elastine
- presence of emilin-1
- presence of collagen type IV and VII. Unit of Measure: % Area
Measured: Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Other inflammatory biomarkers (CD80, CD86, CD40, MHC-II, TLR4; CD11b+, CD14+, TNF-α if inflammatory status) in JULÄINE vs non-treated areas
Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
-Other inflammatory biomarkers such as: CD80 (B7-1), CD86 (B7-2), CD40, MHC-II, TLR4 and in case of an inflammatory status also: CD11b+ CD14+, and TNF-α.
Unit of Measure: Cells count/ mm2 for each biomarker
Measured: Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Investigator-rated improvement of atrophic skin changes in proximity to stretch marks in the JULÄINE-treated thigh compared to baseline, assessed on standardised photographs using a 5-point Global Aesthetic Improvement scale (-1 to +3)
Standardised digital photographs of the JULÄINE-treated thigh are acquired from baseline (Visit 1, before the first injection) through to the end of the study. The investigator compares baseline vs post-treatment photographs side-by-side and rates the change in atrophic skin changes in proximity to stretch marks on a 5-point Global Aesthetic Improvement scale: -1 = worsened (deterioration vs baseline); 0 = no change; +1 = slight improvement; +2 = moderate improvement; +3 = marked improvement. Subjects with no visible stretch marks or atrophic skin changes in the treated area at baseline are classified as Not Applicable and excluded from the analysis.
Measured: Through study completion, an average of 1 year
Evaluation of safety of PLLA LASYNPRO™ JULÄINE
Safety (AEs, SAEs, SADEs)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start13 May 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Model description
- Intra-subject controlled study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordberg Medical Italy srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Responsible party
- Sponsor
- Investigators
- R. Cuomo, Principal investigator, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637188
- Sponsor's protocol ID
- NORD0001
- Other IDs
- CIV-IT-25-10-054855
- Acronym
- Juläine
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Histological Outcomes Following Poly-L-lactic Acid (PLLA) LASYNPRO™ Injections for Skin Laxity Treatment in Patients Requiring Post Bariatric Surgery: A Proof-of-Concept Clinical Study
- ClinicalTrials.gov ID
- NCT07637188
- Acronym / sponsor ID
- Juläine / NORD0001
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nordberg Medical Italy srlIndustry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Study start
- 13 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Jun 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, open-label, intra-subject controlled proof-of-concept clinical study will evaluate the histological and clinical effects of Poly-L-lactic Acid (PLLA) LASYNPRO™ (Juläine) injections for treatment of skin laxity in patients requiring post-bariatric surgery. Fifteen participants will be enrolled. Each participant will serve as his or her own control, with one thigh treated with PLLA LASYNPRO™ and the contralateral thigh left untreated.
Participants will receive 3 injections in the treated thigh over approximately 3 months, followed by planned post-bariatric plastic surgery at 3, 6, or 9 months after the last injection, depending on assigned group. During surgery, tissue samples from treated and untreated areas will be collected for histological evaluation. A follow-up visit will occur approximately 30 days after surgery.
The primary endpoint is comparison of collagen type I and collagen type III between treated and untreated areas. Secondary endpoints include histological comparison of elastic fibers, stromal cell populations, inflammatory biomarkers, cell proliferation markers, and assessment of stretch marks, as well as safety. An exploratory endpoint is assessment of post-operative scar healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-subject controlled study
| Arm | Type | Receives |
|---|---|---|
| Treated thigh | Experimental | Device: PLLA InjectionPLLA injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female aged ≤ 60 years
- Previous bariatric surgery (one anastomosis gastric bypass)
- Stable weight for at least 6 months prior to baseline
- Post-weight loss skin laxity and ptosis requiring surgery
- ΔBMI ≥ 7 defined as the change in BMI from scheduled bariatric surgery to baseline
Key exclusion criteria (11 listed)
- Skin infection or skin inflammation status
- Acute or chronic skin disease
- ΔBMI < 7 defined as the change in BMI from scheduled bariatric surgery to baseline
- BMI > 30
- Male or female aged 60 > years
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 |
|---|---|---|
| PLLA InjectionThree injections | Device | Treated thigh |
Primary outcome
The primary objective of the study is to evaluate the histological effects of PLLA LASYNPRO™ JULÄINE injections in the cutaneous tissue of patients requiring post-bariatric surgery for skin laxity.
Time frame: Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)
Comparison of collagen type I and type III between treated and not treated areas
11 secondary outcomes
Density of elastic fibres in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Percentage of fragmented elastic fibres (elastolysis) in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Stromal cell population in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of Demodex in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of etiological agents of inflammation (CD68, CD3, CD20) in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of etiological agents of inflammation ( Vimentin, CD34,) in JULÄINE treated vs non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of Ki-67 as marker of cell proliferation in JULÄINE-treated and non-treated areas
Time frame: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Presence of fibrilline, elastine, emilin-1 and collagen type IV and VII in JULÄINE vs non-treated areas
Time frame: Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Other inflammatory biomarkers (CD80, CD86, CD40, MHC-II, TLR4; CD11b+, CD14+, TNF-α if inflammatory status) in JULÄINE vs non-treated areas
Time frame: Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
Investigator-rated improvement of atrophic skin changes in proximity to stretch marks in the JULÄINE-treated thigh compared to baseline, assessed on standardised photographs using a 5-point Global Aesthetic Improvement scale (-1 to +3)
Time frame: Through study completion, an average of 1 year
Evaluation of safety of PLLA LASYNPRO™ JULÄINE
Time frame: Through study completion, an average of 1 year
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 9 Jun 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.
R. Cuomo principal investigator
Azienda Ospedaliera Universitaria Senese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLLA Injection in people with Skin Laxity, run by Nordberg Medical Italy srl 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 9 inclusion and 11 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 9 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?
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 A.Piovani (Evidence Generation Project Manager) (+39 0249530047, arianna.piovani@evidilya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to evaluate the histological effects of PLLA LASYNPRO™ JULÄINE injections in the cutaneous tissue of patients requiring post-bariatric surgery for skin laxity. (time frame: Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)). 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 9 Jun 2026.