Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Spectrophotometer measurement
研究概览
简要总结
The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing.
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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18-65 years of age with persistent facial flushing
- •Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.
排除标准
- •Unable to understand the protocol or give informed consent
- •Younger than 18 or older than 65 years of age
- •Females who are pregnant or lactating
- •Known hypersensitivity to BTX-A
- •Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
- •Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma
- •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
- •Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
- •Is planning to use tretinoin or retinoic acid in the next 6 months
- •Has an active infection in the forehead or glabellar region (excluding mild acne)
- •Is allergic to cow's milk protein
- •Is allergic to albumin
- •Is currently using anticoagulation therapy
- •Has a history of bleeding disorders
研究组 & 干预措施
Saline Control
This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.
干预措施: Saline Control (Other)
botulinum toxin A
This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections.
干预措施: botulinum toxin A (Drug)
结局指标
主要结局
Spectrophotometer measurement
时间窗: Baseline and 8 weeks
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
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
Northwestern University