PLLA-LASYNPRO™ Injections for Skin Laxity Treatment (Juläine)
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.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: A.Piovani (Evidence Generation Project Manager)
- Número de telefone: +39 0249530047
- E-mail: arianna.piovani@evidilya.com
Locais de estudo
-
-
-
Siena, Itália
- Recrutamento
- Azienda Ospedaliero Universitaria Senese
-
Contato:
- R.Cuomo
- E-mail: roberto.cuomo2@unisi.it
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treated thigh
PLLA injection
|
Three injections
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Density of elastic fibres in JULÄINE treated vs non-treated areas
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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:
|
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
Prazo: 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)
Prazo: 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
Prazo: Through study completion, an average of 1 year
|
Safety (AEs, SAEs, SADEs)
|
Through study completion, an average of 1 year
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: R. Cuomo, Azienda Ospedaliera Universitaria Senese
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NORD0001
- CIV-IT-25-10-054855 (Outro identificador: Eudamed)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .