市販後の臨床追跡調査によるほうれい線のしわに対する Juläine(TM) の性能と安全性の評価
ほうれい線のしわの治療のための注射用ポリ乳酸皮膚充填剤の性能と安全性を評価するための前向き、単群、介入、多施設、市販後臨床フォローアップ (PMCF) 研究
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.
The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.
Participants will:
Receive 3 rounds of treatment and will be followed up for a total of 2 years.
調査の概要
詳細な説明
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.
The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.
Participants will:
Receive 3 rounds of treatment and will be followed up for a total of 2 years.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Signed Informed Consent Form
- Male or female, ≥18 years old.
- Immune-competent individuals.
- Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.
Exclusion Criteria:
- Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
- Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
- Pigmentation in NLF or having a history of hypo melanosis.
- Susceptibility to keloid formation or hypertrophic scarring.
- History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
- History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
- Hemorrhagic disease or receiving anti-coagulant therapy.
- Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
- Having received in the past 2 months immunosuppressant or systemic steroid therapy.
- Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.
- Female who is pregnant and/or lactating
- Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
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 |
|---|---|
|
実験的：ジュレーヌ
|
Dermal filler (PLLA) |
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 |
|---|---|---|
|
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
時間枠：12 months after final injection
|
Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score. Score 1-5, Higher scores are a worse outcome. |
12 months after final injection
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of subjects with improvement of at least 1 grade on the WSRS.
時間枠：Up to 24 months after final injection
|
Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months). |
Up to 24 months after final injection
|
|
Change in WSRS score
時間枠：Up to 24 months after final injection
|
Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline. Score 1-5, Higher scores are a worse outcome. |
Up to 24 months after final injection
|
|
Mean WSRS of <2 at each follow-up time
時間枠：Up to 24 months after final injection
|
Proportion of subjects with a mean WSRS of <2 at each follow-up time point at 3, 6, 12, and 24 months after final injection. |
Up to 24 months after final injection
|
|
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
時間枠：Up to 24 months after final injection
|
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2. |
Up to 24 months after final injection
|
|
Change Face-Q score of Nasolabial Fold
時間枠：Up to 24 months after final injection
|
Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline. Scores 1-4: high scores better outcome |
Up to 24 months after final injection
|
|
Change in Global Aesthetic in Improvement Scale
時間枠：Up to 24 months after final injection
|
Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline. Scale 1-5; High scores worse outcome |
Up to 24 months after final injection
|
|
Subject Satisfaction Scores
時間枠：Up to 24 months after final injection
|
Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection. Scale 1-5; High scores better outcome |
Up to 24 months after final injection
|
協力者と研究者
スポンサー
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
その他の研究ID番号
- NOR-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。