Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone: A Split-face, Rater-blinded Randomized Control Trial
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
- Measure:
研究概览
简要总结
The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.
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
- Single (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
- •In good health
- •Is 18-65 years of age
- •Has static and dynamic forehead/glabellar wrinkles
- •Has willingness and the ability to understand and provide informed consent and communicate with the investigator
排除标准
- •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 past year
- •semi-permanent soft tissue augmentation material in the past 2 years
- •permanent soft tissue augmentation material
- •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
- •Taking aminoglycoside
- •Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
- •Is currently using anticoagulation therapy
- •Has a history of bleeding disorders
- •Is unable to understand the protocol or to give informed consent
- •Has a mental illness
结局指标
主要结局
Measure:
时间窗: 1 year
Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.
次要结局
- Measure: Percent Improvement(1 year)
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University