PLLA-LASYNPRO™ Injections for Skin Laxity Treatment

ConditionSkin Laxity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorNordberg Medical Italy srl

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

PLLA Injection
Device
Three injections

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Treated thighExperimental treatment 1 intervention

Trial 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

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

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

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

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.

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

Presence of etiological agents related to inflammation (PAS: Demodex) Unit of Measure: Positive/negative

Time frame

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

Other outcomes

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.

Time frame

30 days from post-bariatric surgery for each group

Sponsors and contacts

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Nordberg Medical Italy srl

Lead sponsor

Evidilya S.r.l.

Collaborator

Source ClinicalTrials.gov

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