PLLA-LASYNPRO™ Injections for Skin Laxity Treatment

Nordberg Medical Italy srl15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)

Secondary Outcomes

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