NCT05585398已完成1 期
A Phase 1 Single-center Study to Evaluate the Distribution of NT 201 Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods
研究概览
简要总结
The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject aged 18 to 45 years with body mass index (BMI) 19.0 to 27.0 kg/m².
- •Subject with the distance not less than 45 cm between the spinous process of the 7th cervical vertebra (C7) and the 4th lumbar vertebra (L4).
- •Healthy skin at test area (forehead and back).
- •Fitzpatrick skin type I to IV.
- •Displaying uniform sweating activity (i.e., symmetrical sweating pattern with enough sweat and without anhidrotic regions) on the forehead area as assessed with Minor's starch iodine test under standardized sweating conditions.
排除标准
- •Any chronic pain conditions or presence of acute pain of any origin and intensity.
- •Dermal treatment of the forehead (e.g., light resurfacing, dermabrasions) within the last 12 months before Screening, during the screening period, and/or at Baseline.
- •Any type of filler in the treatment area on the facial region within the last 12 months before Screening, during the screening period, and/or atBaseline; regardless of time for any type of implant and/or surgery in the treatment area on facial region.
- •Any type of surgery in the treatment area of the back within the last 12 months before Screening, during the screening period, and/or at Baseline.
- •Treatment with anticholinergics within the last 14 days before Screening, during the screening period, and/or at Baseline.
- •Treatment with analgesics (e.g., non steroidal anti inflammatory drugs, except acetylsalicylic acid, ibuprofen, and paracetamol) within the last 10 days before Screening, during the screening period, and/or prior to pain assessment at Baseline.
- •Treatment with paracetamol, ibuprofen, or acetylsalicylic acid within three days prior to pain assessment at Baseline.
- •Subjects with excessive sweating or previously diagnosed with hyperhidrosis.
研究组 & 干预措施
LMRC (left with micro-/right with conv- needle)
Experimental
干预措施: IncobotulinumtoxinA (Drug)
RMLC (right with micro-/left with conv- needle)
Experimental
干预措施: IncobotulinumtoxinA (Drug)
LCRM (left with conv-/ right with micro-needles)
Experimental
干预措施: IncobotulinumtoxinA (Drug)
RCLM (right with conv-/left with micro-needles)
Experimental
干预措施: IncobotulinumtoxinA (Drug)
结局指标
主要结局
Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods
时间窗: Week 4
次要结局
- Injection pain intensity as assessed by a 0-10 numeric pain rating scale directly after the intradermal injection of NT 201 applied via different delivery methods in the forehead(Week 4)
研究者
研究点 (1)
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