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首页> 外文期刊>Journal of drugs in dermatology: JDD >Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study
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Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study

机译：在上面面部线治疗中，IncObotulinumtoxina的安全性，耐受性和疗效和疗效：潜在，开放标签，第三阶段研究的结果

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In aesthetic practice, wrinkles in the upper face are commonly treated with repeat-dose injections. The objective of this study was to investigate the safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the combined treatment of moderate to severe upper facial lines (UFL) [glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)]. Healthy subjects (>= 18 years) with moderate to severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contraction were administered 54 to 64 U of incobotulinumtoxinA (GFL, 20 U; HFL, 10 to 20 U; LPL, 24 U) in up to four, 120-day treatment cycles. Adverse events (AE) were recorded for each cycle until 120 +/- 7 days after treatment. Investigator-assessed MAS scores were evaluated for each treated area at maximum contraction on day 30 [responder = score of "none" (0) or "mild" (1)]. Subject-assessed scores for overall appearance of the upper face of "much improved" or "very much improved" were noted at day 30 of each treatment cycle on the Global Impression of Change Scale (GICS). Overall, 140 subjects were treated, and 125 subjects completed the study. Mean injected units per injection cycle ranged from 56.3 U to 577 U. During the four-cycle study period 171% of total treated subjects experienced a treatment emergent adverse event (TEAE). TEAEs of special interest were documented for 9 subjects (6.4%), in 6 of these subjects (4.3%) the TEAEs were related to treatment. No clinically significant mean changes in laboratory and vital-sign values were observed from screening to final-treatment visit. Over the study interval, a response rate of > 80% on the investigator-assessed MAS was reported for all treated areas except HFL. Greater than 80% of subjects in cycles 1, 3, and 4 and 78.5% of subjects in cycle 2 reported ratings of "much improved" or "very much improved" on the GICS for the overall appearance of the upper face. IncobotulinumtoxinA for the repeat-dose treatment of UFL is safe and well tolerated with a stable safety profile, without new formation of neutralizing antibodies and has excellent efficacy during prolonged administration.
机译：在审美实践中，上面的皱纹通常用重复剂量注射治疗。本研究的目的是探讨重复剂量注射IncobotiNumtoxina的安全性，耐受性和疗效在中度至重度上面部线（UFL）[Glabellar皱眉线（GFL），水平前额线（HFL）的组合治疗中和侧面眶周（LPL）]。在最大收缩的Merz美学鳞片（MAS）上具有中度至严重GFL，HFL和LPL的健康受试者（> = 18岁）以Incobotulinumtoxina（Gfl，20 u; Hfl，10至20 u; LPL，24 u）最多四个，120天治疗循环。对每个循环记录不良事件（AE），直至治疗后120 +/- 7天。在第30天的最大收缩时，对每个处理区域评估调查仪评估的MAS分数[响应者=“无”（0）或“轻度”（1））。在每次治疗周期的全球变化量表（GICS）的全球印象中，在每次治疗周期的第30天，注意到“大大改善”或“非常改善”的总体外观的主题评估分数。总体而言，治疗了140名受试者，125名受试者完成了该研究。每个注射循环的平均注射单位范围为56.3 u至577 u。在四周期研究期间，171％的治疗期间的171％经历了治疗急性不良事件（茶）。特殊兴趣的茶叶被记录在其中9个受试者（6.4％），其中6个受试者（4.3％）茶与治疗有关。从筛选到最终治疗访问，观察到实验室和生命符号值的临床上显着的平均变化。通过研究间隔，除HFL外的所有治疗区域报告了调查员评估的MAS上的响应率> 80％。在循环1,3和4和48.5％的循环2中的受试者中大于80％的受试者的受试者的受试者的受试者的循环2中的受试者报告了上面整体外观的基础上的“大得多”或“非常改善”的评级。对于UFL的重复剂量处理的INCOBOTURINUMTOXINA具有稳定的安全性曲线安全且耐受，无需新的中和抗体形成并且在长时间给药期间具有优异的功效。

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