PLLA-LASYNPRO™ Injections for Skin Laxity Treatment (Juläine)

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Laxity
• Intervention / Treatment: Device: PLLA Injection

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A.Piovani (Evidence Generation Project Manager); Phone Number: +39 0249530047; Email: arianna.piovani@evidilya.com

Study Locations

• Italy
  • Siena, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria Senese
    • Contact: R.Cuomo; Email: roberto.cuomo2@unisi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Pittsburgh scale rating ≥10
• Ability to give written informed consent
• Willing to participate in the study and attending the visits

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated thigh; PLLA injection	Device: PLLA Injection; Three injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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	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	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: %	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 (%)	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	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	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.	Through study completion, an average of 1 year
Evaluation of safety of PLLA LASYNPRO™ JULÄINE	Safety (AEs, SAEs, SADEs)	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects by post-operative wound appearance category (well healed / mild inflammation / dehiscence / infection / other) in the JULÄINE-treated thigh compared to the untreated thigh, assessed on physical examination	At the follow-up visit (Visit 5, 30 days after post-bariatric surgery and biopsy) the investigator performs a physical examination of the surgical wound on both the JULÄINE-treated thigh and the contralateral untreated thigh (intra-subject control). Wound appearance is classified by the investigator into one of the following categories: well healed, mild inflammation, dehiscence, infection, or other (specified). The outcome is reported as the number and proportion of subjects in each wound-appearance category, separately for the treated thigh and the untreated thigh.	30 days from post-bariatric surgery for each group

Collaborators and Investigators

• Sponsor: Nordberg Medical Italy srl
• Collaborators: Evidilya S.r.l.
• Investigators: Principal Investigator: R. Cuomo, Azienda Ospedaliera Universitaria Senese

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Cutis Laxa
• Other Study ID Numbers: NORD0001; CIV-IT-25-10-054855 (Other Identifier: Eudamed)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No