PLLA-LASYNPRO™ Injections for Skin Laxity Treatment

NCT07637188 | Recruiting

• 2 other identifiers: NORD0001CIV-IT-25-10-054855
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Density of elastic fibres in JULÄINE treated vs non-treated areas

  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

  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

  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

  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

  Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)

Other Outcomes (1)

• 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

  30 days from post-bariatric surgery for each group

Study Arms (1)

Treated thigh

EXPERIMENTAL

PLLA injection

Device: PLLA Injection

Interventions

PLLA Injection DEVICE

Three injections

Treated thigh

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordberg Medical Italy srl: lead
• Evidilya S.r.l.: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Senese

Siena, Italy

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• R. Cuomo

  Azienda Ospedaliera Universitaria Senese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A.Piovani (Evidence Generation Project Manager)

CONTACT

+39 0249530047; arianna.piovani@evidilya.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-subject controlled study

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 9, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

IT (1)