KCT0001445已完成未知
A Randomized, Multi-center, Patient & Evaluator-blind, Matched pairs, Active-controlled design Clinical study to Evaluate the Efficacy and Safety of Injection with Dermalax (Deep) as Compared to Restylane® in Correction of Nasolabial fold
Across0 个研究点目标入组 66 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 30(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1.Male or female subjects no younger than 30 and no more than 65 years of age.
- •2.Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)
- •*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.
排除标准
- •1.Subjects who show hypersensitive skin reaction to the investigational devices, confirmed by the intradermal reaction test performed at screening.
- •2.Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day) or NSAIDs or Vitamin E within 1 week.
- •3.Subjects with a liver problem and/or blood coagulation defect or subjects who require the administration of an antithrombotic agent during the clinical trial period (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day).
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