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

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

15

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treated thigh
PLLA injection
Dispositivo: PLLA Injection
Three injections

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Density of elastic fibres in JULÄINE treated vs non-treated areas
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Through study completion, an average of 1 year
Safety (AEs, SAEs, SADEs)
Through study completion, an average of 1 year

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nordberg Medical Italy srl

Collaboratori

Evidilya S.r.l.

Investigatori

  • Investigatore principale: R. Cuomo, Azienda Ospedaliera Universitaria Senese

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 maggio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NORD0001
  • CIV-IT-25-10-054855 (Altro identificatore: Eudamed)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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