英科博妥素A是治疗上半脸皱纹的一种有效且耐受性良好的疗法：一项III期研究开放标签延长期的结果

IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.

作者信息

Trevidic Patrick, Connolly Simon A, Biwer Bernard, Ellers-Lenz Barbara, Harrington Laura S, Kestemont Philippe, Noah Ernst M, Sattler Gerhard, Weissenberger Petra, Kerscher Martina

机构信息

*Expert2Expert, Paris, France; †Regency Medical Clinic, Glasgow, United Kingdom; ‡Private Practice for Skin Diseases, Allergology and Aesthetic Dermatology, Ludwigshafen, Germany; §Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; ‖Ogilvy Healthworld, Oxford, United Kingdom; ¶Clinique Esthétique St George, Nice, France; #Department for Plastic, Reconstructive and Aesthetic Surgery, Red Cross Hospital, Kassel, Germany; **Rosenparkklinik, Darmstadt, Germany; and ††Division of Cosmetic Science, University of Hamburg, Hamburg, Germany.

出版信息

Dermatol Surg. 2017 Dec;43 Suppl 3:S285-S292. doi: 10.1097/DSS.0000000000001416.

DOI:10.1097/DSS.0000000000001416

PMID:33065954

Abstract

BACKGROUND

In clinical practice, different upper facial areas are commonly treated together.

OBJECTIVE

To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period.

MATERIALS AND METHODS

In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores.

RESULTS

A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.

CONCLUSION

IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

摘要

背景

在临床实践中，通常会对不同的上半面部区域进行联合治疗。

目的

在为期3个月的开放标签延长期（OLEX）中，评估重复注射incobotulinumtoxinA治疗上半面部皱纹（UFL）的疗效和安全性。

材料与方法

在主要研究阶段（随机、双盲、安慰剂对照；n = 156），在5分制的默茨美学量表（MAS）上有中度至重度UFL（眉间皱眉纹[GFL]、额部水平纹[HFL]和眶周外侧纹[LPL]）的受试者接受54至64 U的incobotulinumtoxinA或安慰剂。在OLEX中，所有受试者（n = 139）接受一次54至64 U的incobotulinumtoxinA治疗。在静息和最大收缩时评估研究者和受试者评定的MAS评分。反应定义为MAS评分为“无”或“轻度”，或MAS评分提高≥1分。