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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-IT-25-10-054855 | Other Identifier | Eudamed |
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| Name | Class |
|---|---|
| Evidilya S.r.l. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated thigh | Experimental | PLLA injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLLA Injection | Device | Three injections |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A.Piovani (Evidence Generation Project Manager) | Contact | +39 0249530047 | arianna.piovani@evidilya.com |
| Name | Affiliation | Role |
|---|---|---|
| R. Cuomo | Azienda Ospedaliera Universitaria Senese | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Senese | Recruiting | Siena | Italy |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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Intra-subject controlled study
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| 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 | 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. | 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 | 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 | 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 | -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 | 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 | Histological evaluation and comparison between JULÄINE treated and non-treated areas of:
| 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 | 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) | 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 | Safety (AEs, SAEs, SADEs) | Through study completion, an average of 1 year |
| 30 days from post-bariatric surgery for each group |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |