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

5 juni 2026 bijgewerkt door: Nordberg Medical Italy srl

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treated thigh
PLLA injection
Apparaat: PLLA Injection
Three injections

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Density of elastic fibres in JULÄINE treated vs non-treated areas
Tijdsspanne: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)

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

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

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

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
Tijdsspanne: Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
-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
Tijdsspanne: 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. 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
Tijdsspanne: Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)

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

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)
Tijdsspanne: Through study completion, an average of 1 year
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
Tijdsspanne: Through study completion, an average of 1 year
Safety (AEs, SAEs, SADEs)
Through study completion, an average of 1 year

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 30 days from post-bariatric surgery for each group
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nordberg Medical Italy srl

Medewerkers

Evidilya S.r.l.

Onderzoekers

  • Hoofdonderzoeker: R. Cuomo, Azienda Ospedaliera Universitaria Senese

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 mei 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NORD0001
  • CIV-IT-25-10-054855 (Andere identificatie: Eudamed)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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