Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Frankfurt、ドイツ、60318
- Merz Pharmaceuticals GmbH
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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:
- Moderate to severe glabellar frown lines
Exclusion Criteria:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
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実験的：20 U NT 201
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Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
他の名前：
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実験的：10 U NT 201
|
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
他の名前：
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実験的：30 U NT 201
|
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
他の名前：
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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 |
|---|---|---|
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Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
時間枠：Baseline (Day 0) to Day 30
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
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Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
時間枠：Baseline (Day 0) to Day 30
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Responders will be subjects with at least a 1-point improvement compared to Day 0. The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
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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 |
|---|---|---|
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Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
時間枠：Baseline (Day 0) to Day 90
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
時間枠：Baseline (Day 0) to Day 90
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Responders will be subjects with at least a 1-point improvement compared to Day 0. Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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協力者と研究者
捜査官
- スタディチェア：Merz Pharmaceuticals、Merz Pharmaceuticals GmbH
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- MRZ 60201-0527/1
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