EUCTR2011-005887-20-GB进行中（未招募）1 期
A prospective, randomized, double-blind, placebo-controlled,multicenter study with an open-label extension period toinvestigate the efficacy and safety of NT 201 in the combinedtreatment of upper facial lines (horizontal forehead lines,glabellar frown lines, and lateral periorbital lines) - Investigation of efficacy and safety of NT201 in Upper Facial lines
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Outpatients (male or female) 18 years of age or older.
- •Calculated cut-off score below 0 in evaluation based on the Freiburg
- •Life Quality Assessment - 'Lebensqualität, Haut und Kosmetik'
- •Questionnaire [FLQA-k]).
- •HFL, GFL, and symmetrical LPL of moderate to severe intensity at
- •maximum contraction as assessed by the investigator according to the
- •Merz Aesthetics Scales.
- •Stable medical condition.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Main Period:
- •Previous treatment with Botulinum toxin of any serotype in the
- •forehead, glabellar, and/or periorbital area within the last 6 months
- •before injection.
- •Previous treatment with any facial cosmetic procedure (e.g. dermal
- •filling,chemical peeling, photo rejuvenation) in the forehead, glabellar,
- •and/or periorbitalarea within the last 8 months before injection.
- •Any previous insertion of permanent material in the forehead,
- •glabellar, and/or periorbital area (regardless of the time between previous treatment and this study).
- •Planned treatment with Botulinum toxin of any serotype in the face
- •during the study period.
- •Any other planned facial cosmetic procedure in the face during the
- •study period.
- •Very severe lines (HFL, GFL, and/or LPL) at maximum contraction as
- •assessed by the investigator according to the Merz Aesthetics Scales.
- •Inability to substantially lessen UFL (HFL, GFL, LPL) by physically
- •spreading them apart.
- •Any surgery or scars in the forehead, glabellar, or periorbital area.
- •Marked facial asymmetry.
- •Eyelid ptosis.
- •Marked brow ptosis.
- •History of facial nerve palsy.
- •Any infection and/or inflammation at the planned injection points.
研究者
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