Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
A Prospective Multi-Center, Evaluator- and Subject- Blinded, Randomized Study to Evaluate the Safety and Effectiveness of NOA LIFT Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds
Nasolabial folds (NLFs) are wrinkles that run from the sides of the nose to the corners of the mouth. The goal of this study is to evaluate how safe and effective NOA LIFT is compared to JUVÉDERM VOLIFT with Lidocaine for correcting moderate to severe nasolabial folds in adults.
NOA LIFT and JUVÉDERM VOLIFT with Lidocaine are hyaluronic acid-based dermal fillers being evaluated for the treatment of nasolabial folds. Participants are randomly placed into 1 of 2 treatment groups. There is a 2 in 3 chance that participants will be assigned to the NOA LIFT group and a 1 in 3 chance of being assigned to the VOLIFT group. Around 288 adult participants with moderate to severe nasolabial folds will be enrolled at multiple sites in China.
Participants will receive deep dermis injections of either NOA LIFT or JUVÉDERM VOLIFT. The study duration is approximately 12 months after the initial treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, vital signs, laboratory tests, vision assessments, checking for side effects, and completing questionnaires.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100032
- 募集
- Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457
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Guangdong
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Guangzhou、Guangdong、中国、510280
- 募集
- Zhujiang Hospital /ID# 276566
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Shenzhen、Guangdong、中国、518036
- 募集
- Peking University Shenzhen Hospital /ID# 268255
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Jiangsu
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Nanjing、Jiangsu、中国、210008
- 募集
- Nanjing Drum Tower Hospital /ID# 267555
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Nanjing、Jiangsu、中国、210009
- 募集
- Zhongda Hospital Of Southeast University /ID# 276571
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Shaanxi
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Xianyang、Shaanxi、中国、712000
- 募集
- Xianyang Hospital of Yanan University /ID# 267936
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Moderate (2) or Severe (3) on the 5-point Nasolabial Fold Severity Scale (NLFSS) for each nasolabial fold (NLF) on evaluator live assessment (both sides must qualify and have the same score)
Exclusion Criteria:
- Current cutaneous or mucosal inflammatory or infectious processes, abscess, unhealed wound, or cancerous or precancerous lesion in the treatment area(s).
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：NOA LIFT
Participants will receive initial treatment with NOA LIFT injected into the nasolabial folds.
Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.
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Injection
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アクティブコンパレータ：JUVÉDERM VOLIFT With Lidocaine
Participants will receive initial treatment with JUVÉDERM VOLIFT with Lidocaine injected into the nasolabial folds.
Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.
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Injection
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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 |
|---|---|---|
|
Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS)
時間枠：Month 6
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The NLFSS is a validated 5-point scale used to assess the severity of nasolabial folds, where higher scores indicate more severe folds.
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Month 6
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Number of Participants With Adverse Events
時間枠：Up to approximately 13 months
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Up to approximately 13 months
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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 |
|---|---|---|
|
Percentage of Participants With Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)
時間枠：Month 6
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A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS).
The GAIS is used to assess aesthetic improvement, with higher ratings indicating greater improvement.
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Month 6
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Percentage of Participants With Responder Status Based on Participant's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)
時間枠：Month 6
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A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS).
The GAIS is used by participants to assess their own aesthetic improvement, with higher ratings indicating greater improvement.
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Month 6
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Change From Baseline in the Overall Score of FACE-Q - Appraisal of Lines: Nasolabial Folds
時間枠：Up to Month 6
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The FACE-Q - Appraisal of Lines: Nasolabial Folds is a patient-reported outcome measure assessing satisfaction with nasolabial fold appearance.
Higher scores indicate better outcomes.
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Up to Month 6
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：ABBVIE INC.、AbbVie
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
キーワード
その他の研究ID番号
- M23-066
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国で製造され、米国から輸出された製品。
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