PLLA-LASYNPRO™ Injections for Skin Laxity Treatment

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

Overview

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.

Interventions

• Device PLLA Injection
  Three injections

Primary outcome measures

• 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)]

Secondary outcome measures (11)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Azienda Ospedaliero Universitaria Senese — Siena

Identifiers

NCT: NCT07637188 · NORD0001 · CIV-IT-25-10-054855

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗