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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：A.Piovani (Evidence Generation Project Manager)
- 電話番号：+39 0249530047
- メール：arianna.piovani@evidilya.com
研究場所
-
-
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Siena、イタリア
- 募集
- Azienda Ospedaliero Universitaria Senese
-
コンタクト：
- R.Cuomo
- メール：roberto.cuomo2@unisi.it
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treated thigh
PLLA injection
|
Three injections
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)
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Comparison of collagen type I and type III between treated and not treated areas
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Group 1 (6 months from baseline visit), Group 2 (9 months from baseline visit), Group 3 (12 months from baseline visit)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Density of elastic fibres in JULÄINE treated vs non-treated areas
時間枠：Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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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)
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Percentage of fragmented elastic fibres (elastolysis) in JULÄINE treated vs non-treated areas
時間枠：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)
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|
Stromal cell population in JULÄINE treated vs non-treated areas
時間枠：Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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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
時間枠：Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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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)
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Presence of etiological agents of inflammation (CD68, CD3, CD20) in JULÄINE treated vs non-treated areas
時間枠：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
時間枠：Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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-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)
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Presence of Ki-67 as marker of cell proliferation in JULÄINE-treated and non-treated areas
時間枠：Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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Presence of Ki-67 as marker of cell proliferation.
Unit of measure: percentage of Ki-67-positive cells (%)
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Group 1 ( 6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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Presence of fibrilline, elastine, emilin-1 and collagen type IV and VII in JULÄINE vs non-treated areas
時間枠：Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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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)
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Other inflammatory biomarkers (CD80, CD86, CD40, MHC-II, TLR4; CD11b+, CD14+, TNF-α if inflammatory status) in JULÄINE vs non-treated areas
時間枠：Group 1 (6 months from baseline), Group 2 (9 months from baseline), Group 3 (12 months from baseline)
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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)
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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)
時間枠：Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Evaluation of safety of PLLA LASYNPRO™ JULÄINE
時間枠：Through study completion, an average of 1 year
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Safety (AEs, SAEs, SADEs)
|
Through study completion, an average of 1 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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.
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30 days from post-bariatric surgery for each group
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協力者と研究者
協力者
捜査官
- 主任研究者：R. Cuomo、Azienda Ospedaliera Universitaria Senese
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NORD0001
- CIV-IT-25-10-054855 (その他の識別子：Eudamed)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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