The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual analog score (VAS) pain rating after each side is injected
研究概览
简要总结
The purpose of this study is to compare the levels of pain resulting from injections of Botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).
详细描述
Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. This study is a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In good health
- •Is a female
- •Is 25-70 years of age
- •Has moderate dynamic forehead/glabellar wrinkles
- •Has willingness and the ability to understand and provide informed consent and communicate with the study staff
排除标准
- •Younger than 25 or older than 70 years of age
- •Pregnant or lactating
- •Has received the following treatments in the forehead or glabellar region:
- •botulinum toxin injections in the past 6 months
- •ablative laser procedure in the past 6 months
- •radiofrequency device treatment in the past 6 months
- •ultrasound device treatment in the past 6 months
- •medium to deep chemical peel in the past 6 months
- •temporary soft tissue augmentation material in the area to be treated in the past year
- •semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
- •permanent soft tissue augmentation material in the area to be treated
- •Has an active infection in the forehead or glabellar region (excluding mild acne)
- •Is allergic to cow's-milk protein
- •Is allergic to albumin
- •Taking aminoglycoside
- •Is currently using anticoagulation therapy
- •Has a history of bleeding disorders
- •Has a mental illness
- •Unable to understand the protocol or to give informed consent
结局指标
主要结局
Visual analog score (VAS) pain rating after each side is injected
时间窗: 1 hour on Treatment day
Subjects will rate pain using the visual analog score (VAS 1-10) after each side is injected using the 30 or 32 gauge needles. Lower values represents less pain; higher values represents more pain.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University