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临床试验/NCT02703740
NCT02703740已完成不适用

Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

Laboratoires Genévrier1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Number and description of adverse events that are related to treatment

研究概览

简要总结

This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

详细描述

Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is at least 19 years of age.
  • Has Fitzpatrick Skin Type IV, V, or VI.
  • Has a WSRS score > or = to 3 for both NLF
  • Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months

排除标准

  • Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs
  • Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
  • Has nasolabial folds that are too severe to be corrected in one treatment session.
  • Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
  • Is pregnant, lactating, or not using acceptable contraception.

研究组 & 干预措施

HA 20 mg/mL

Experimental

干预措施: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)

HA 24 mg/mL

Experimental

干预措施: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)

结局指标

主要结局

Number and description of adverse events that are related to treatment

时间窗: 1 month

次要结局

  • Number and description of adverse events that are related to treatment(72h/3 months/6 Months/9 months/12 months)
  • Treatment efficacy assessed by WSRS(1/3/6/9/12 months)

研究者

发起方
Laboratoires Genévrier
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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