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

5 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treated thigh
PLLA injection
Dispositif: PLLA Injection
Three injections

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Density of elastic fibres in JULÄINE treated vs non-treated areas
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: Through study completion, an average of 1 year
Safety (AEs, SAEs, SADEs)
Through study completion, an average of 1 year

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nordberg Medical Italy srl

Collaborateurs

Evidilya S.r.l.

Les enquêteurs

  • Chercheur principal: R. Cuomo, Azienda Ospedaliera Universitaria Senese

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 mai 2026

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

5 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NORD0001
  • CIV-IT-25-10-054855 (Autre identifiant: Eudamed)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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