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一项评估 IPN10200 在中度至重度上面部线条成人参与者中的安全性和有效性的研究 (LANTIC)

2026年9月3日 更新者：Ipsen

一项 Ib/II 期、多中心、双盲、随机、安慰剂对照、剂量递增和剂量探索研究，以评估 IPN10200 在改善成人中度至重度上面部线条外观方面的安全性和有效性

本研究的目的是评估增加剂量的 IPN10200 与安慰剂相比的安全性和有效性，目的是发现用于治疗中度至重度疾病时提供最佳有效性/安全性的剂量上面部线条。

这项研究将分三个阶段进行。 完整研究（包括所有阶段）最多将有 448 名参与者。 该协议目前已获批至第 1 阶段、第 1 步和第 1 阶段/第 2 步。

第一阶段（第一阶段和第二阶段）

  • 第 1 步（Ib 阶段）：对患有中度至重度眉间纹 (GL) 的参与者进行首次剂量递增
  • 第 2 步（第二阶段）：与 Dysport 相比，中度至重度 GL 参与者的剂量发现步骤

第二阶段（第二阶段）

- 评估 IPN10200 在以下区域之一的疗效和安全性：GL + 前额线 (FHL) 或外眦线 (LCL)

第三阶段（第二阶段）

- IPN10200 在所有三个地区（GL、FHL 和 LCL）的安全性和有效性评估

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

727

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Berlin、德国、13353
        • CRS Clinical Research Services Berlin GMBH
      • Berlin、德国
        • Interdisciplinary Study Association
      • Darmstadt、德国
        • Rosenpark Research GmbH
      • Düsseldorf、德国
        • Privatpraxis Dr. Hilton & Partner
      • Hamburg、德国
        • Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
      • Mahlow、德国
        • Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
    • State of Berlin
      • Kassel、State of Berlin、德国
        • Interdisciplinary Study Association
  • 法国
      • Antibes、法国
        • MEDITI - Clinique Del Mar
      • Lyon、法国
        • Aimed S.A.S
      • Paris、法国
        • Clinique de Chirurgie Esthétique Iéna

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 在签署知情同意书时，参与者必须年满 18 至 65 岁（含）。
  2. 中度或重度（2 级或 3 级）GL 在基线最大收缩时，由 ILA 使用经过验证的 4 点摄影量表评估。
  3. 中度或重度（2 级或 3 级）GL 在基线最大收缩时，由 SSA 使用经过验证的 4 点分类量表评估。
  4. 不满意或非常不满意（2 级或 3 级）他们的线在基线，由 SLS 评估。

排除标准：

  1. 上面部的活动性感染或其他皮肤问题，包括 GL、FHL 和 LCL 区域（例如 急性痤疮病变或溃疡）。
  2. 过去 5 年内有眼睑整形术或提眉术史
  3. 面神经麻痹病史。
  4. 明显的面部不对称、上睑下垂、过度皮肤松弛、深层真皮疤痕或厚皮脂。
  5. 任何已知的可能使参与者在暴露于任何血清型 BoNT（即 重症肌无力、伊顿-兰伯特综合征、肌萎缩侧索硬化症等）
  6. 患有 COVID-19 疾病或 SARS-CoV-2 检测呈阳性，或存在任何其他病症（例如 神经肌肉疾病或其他可能干扰神经肌肉功能的疾病）
  7. 先前使用任何 BoNT 血清型进行第 1 阶段/第 1 阶段的治疗或任何最近（在基线之前的过去 6 个月内）使用任何 BoNT 血清型进行第 1 阶段/第 2 阶段的治疗。
  8. 之前在上脸（包括 GL、FHL 和 LCL 区域）使用永久性填充剂进行的任何治疗。
  9. 在过去 3 年内对包括 GL 区域在内的上面部进行过任何长效真皮填充剂治疗和/或在过去 5 年内进行皮肤擦伤/表面重修（无论使用何种介入技​​术），或光子嫩肤或皮肤/血管激光介入在基线之前的 12 个月内。
  10. 研究期间任何计划的面部整容手术。
  11. 使用研究者认为会干扰研究干预的安全性或有效性评估的伴随疗法，包括影响出血性疾病的药物（例如 用于治疗或预防心脑血管疾病的抗血小板剂和/或抗凝剂）。
  12. 在基线之前的过去 30 天内使用影响神经肌肉传递的药物，例如箭毒样非去极化剂、林可酰胺、多粘菌素、抗胆碱酯酶和氨基糖苷类抗生素。
  13. 在 30 天内使用任何实验设备或在相应药物或其代谢物记录的终末半衰期的五倍内使用任何实验药物治疗，或者如果在研究开始前 30 天内半衰期未知（在基线之前）和研究进行期间。
  14. 已知乙型肝炎抗原或丙型肝炎病毒抗体阳性，或人类免疫缺陷病毒 (HIV) 阳性或获得性免疫缺陷综合征的诊断。
  15. 临床诊断为严重的焦虑症，或任何其他严重的精神疾病（例如 抑郁症）可能会干扰参与者参与研究
  16. 研究者确定，即使通过物理方式将它们分开，也无法显着减轻 GL 和/或水平前额皱纹。
  17. 已知对 BoNT 或 IPN10200 或 Dusport/Azzalure 的任何赋形剂过敏或过敏，或对牛奶蛋白过敏。
  18. 吸毒或酗酒史
  19. 不愿采用高效避孕方法的孕妇、哺乳期妇女、绝经前妇女或育龄妇女
  20. 未进行输精管切除术且有生育潜力的女性伴侣并且在整个研究参与过程中不愿意使用含有杀精子剂的避孕套的男性参与者。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：Dysport Group（仅第1阶段和第3阶段）
生物：Dysport
仅在第1阶段和第3阶段进行研究干预措施
实验性的：Corabotase group

Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 (Corabotase:placebo)in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation.

Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase: placebo:dysport) The decision to escalate to the next dose for each cohort will be based on DMC recommendation .

Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo).

Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.
生物：Corabotase

Stage 1: Several different doses will be administrated in a dose-escalation manner.

One single injection will be injected locally into several sites across the glabellar region.

Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions.

Stage 3: One single injection will be injected locally into several sites across the upper facial area.
安慰剂比较：Placebo group

Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation.

Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase:Corabotase: placebo) The decision to escalate to the next dose for each cohort will be based on DMC recommendation.

Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo).

Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.(Corabotase:placebo)
生物：IPN10200安慰剂

第1阶段：一项单一的研究干预措施将在局部注射到整个Glabellar区域的几个地点。

第2阶段：一台注射将在局部注射到Glabellar，额头和侧面区域的几个位置。

第3阶段：一次注射将在局部注射到上部面部区域的几个地点。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
每次剂量的治疗出现不良事件（TEAE）的发生率
大体时间：从基线到研究结束（9个月）
在第1阶段/步骤1，第3阶段
从基线到研究结束（9个月）
每次剂量的严重不良事件（SAE）发生率
大体时间：从基线到研究结束（9个月）
在第1阶段/步骤1，第3阶段
从基线到研究结束（9个月）
不良事件（AES）（或SAE）的发生率导致提款和不利事件特殊感兴趣（AES）
大体时间：从基线到研究结束（9个月）
在第1阶段/步骤1，第3阶段
从基线到研究结束（9个月）
Response to treatment at Stage 2 for the FHL group
大体时间：At Week 4

Measured by the composite response of ≥ 2-grade improvement on Investigator's Live Assessment (ILA) and subject's self-assessment (SSA) at maximum contraction on the forehead lines:

ILA: a validated 4-point photographic scale to assess the severity and appearance of the Forehead Lines (FHL) at maximum frown and at rest where 0 is "none" and 3 is "severe"

SSA: a validated 4-point categorical scale to assess the appearance of their FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
At Week 4
Response to treatment at Stage 2 for the glabellar lines (GL)+ FHL group
大体时间：At Week 4

Measured by the composite response of ≥ 2-grade improvement on ILA and SSA at maximum contraction on the forehead lines (FHL) area:

ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs and FHLs at maximum frown and at rest where 0 is "none" and 3 is "severe"

SSA: a validated 4-point categorical scale to assess the appearance of their GLs and FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
At Week 4
Response to treatment at Stage 2 for the LCL group
大体时间：At Week 4

Measured by the composite response of ≥ 2-grade improvement ILA and SSA at maximum contraction on both sides of the lateral canthal lines (LCL) area:

ILA: a validated 4-point photographic scale to assess the severity and appearance of the LCLs at maximum frown and at rest where 0 is "none" and 3 is "severe"

SSA: a validated 4-point categorical scale to assess the appearance of their LCLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
At Week 4
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
大体时间：From the baseline to the end of the study (6 years, 5 months)
Double Blind phase. Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings
大体时间：From the baseline to the end of the study (6 years, 5 months)
Double Blind phase.
From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination.
大体时间：From the baseline to the end of the study (6 years, 5 months)
Double Blind phase. Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
From the baseline to the end of the study (6 years, 5 months)

次要结果测量

结果测量
措施说明
大体时间
受试者满意度 (SLS) 得分为“非常满意”或“满意”时对治疗的反应
大体时间：从基线到研究结束（9 个月）
从基线到研究结束（9 个月）
Percentage of participants response to treatment.
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)

For all stages. Measured by the composite response of ≥ 2-grade improvement on ILA and SSA for each concerned facial area in each respective stage (GL/LCL/FHL)

ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs/LCLs/FHLs in each respective stage at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced"

SSA: a validated 4-point categorical scale to assess the appearance of their GLs/LCLs/FHLs in each respective stage at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the ILA at maximum contraction for each concerned facial area
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages.
From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages. Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest on each facial area
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages
From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the SSA at maximum contraction for each concerned facial area
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages.
From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction for each concerned facial area.
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
Stage 2 and Stage 3.
From the baseline to the end of the study (up to 6 years, 5 months)
Duration of treatment response based on ILA and SSA at maximum contraction for each concerned facial area
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages.
From the baseline to the end of the study (up to 6 years, 5 months)
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines for each concerned facial area
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
For all stages.
From the baseline to the end of the study (up to 6 years, 5 months)
Satisfaction with facial appearance, measured by Facial Appearance Overall scale score on the Face-Q satisfaction scale
大体时间：From the baseline to the end of the study (up to 6 years, 5 months)
Stage 3. Face Q is a participant-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the participant's perspective. The Face Q instrument is composed of over 40 scales, covering four domains (Satisfaction with Facial Appearance, Health Related Quality of Life, Adverse Effects, and Process of Care).
From the baseline to the end of the study (up to 6 years, 5 months)
Satisfaction with facial appearance, measured by FACE-Q Short Form Facial Appearance scale score.
大体时间：From the baseline to the end of the study (6 years, 5 months)
Stage 3. The FACE-Q Short Form Facial Appearance scale is a participant-reported outcome instrument. It asks how dissatisfied or satisfied the participant is with their upper facial lines (UFL) (GL+FHL+LCL). The scale ranges from very dissatisfied to very satisfied.
From the baseline to the end of the study (6 years, 5 months)
Incidence, severity and nature of treatment emergent adverse events (TEAEs)
大体时间：From baseline to the end of the study (up to 6 years, 5 months)
All stages (except Stage 1/Step 1)
From baseline to the end of the study (up to 6 years, 5 months)
Incidence, severity and nature of serious adverse events (SAEs)
大体时间：From baseline to the end of the study (up to 6 years, 5 months)
All stages (except Stage 1/Step 1)
From baseline to the end of the study (up to 6 years, 5 months)
Incidence, severity and nature of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
大体时间：From baseline to the end of the study (up to 6 years, 5 months)
All stages (except Stage 1/Step 1)
From baseline to the end of the study (up to 6 years, 5 months)
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
大体时间：From baseline to the end of the study (6 years, 5 months)
All stages (except Stage 1/Step 1). Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
From baseline to the end of the study (6 years, 5 months)
Time between two consecutive injections
大体时间：From baseline to the end of the study (up to 6 years, 5 months)
Stage 1/Step 3 .
From baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants with binding antibodies to IPN10200
大体时间：At Week 4 , Week 24 and Week 36
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
At Week 4 , Week 24 and Week 36
Percentage of participants with neutralising antibodies to IPN10200
大体时间：At Week 4 , Week 24 and Week 36
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
At Week 4 , Week 24 and Week 36
Percentage of participants with binding antibodies to BontA
大体时间：At Week 4 , Week 24 and Week 36
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
At Week 4 , Week 24 and Week 36
Percentage of participants with neutralising antibodies to BontA
大体时间：At Week 4 , Week 24 and Week 36
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
At Week 4 , Week 24 and Week 36

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ipsen

调查人员

  • 研究主任：Ipsen Medical Director、Ipsen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月6日

初级完成 (估计的)

2026年8月31日

研究完成 (估计的)

2027年8月19日

研究注册日期

首次提交

2021年3月26日

首先提交符合 QC 标准的

2021年3月26日

首次发布 (实际的)

2021年3月29日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • D-FR-10200-002
  • 2024-512782-14-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以请求访问患者水平数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、带注释的病例报告表、统计分析计划和数据集规范。 患者级别的数据将被匿名化，研究文件将被编辑，以保护研究参与者的隐私。

任何请求应提交至 www.vivli.org 由独立的科学审查委员会进行评估。

IPD 共享时间框架

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IPD 共享访问标准

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药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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