Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.
详细描述
Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males
- •In good health
- •Is 20-65 years of age
- •Has static and 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
- •Pregnant or lactating
- •Younger than 20 or older than 65 years of age
- •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
- •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
- •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
研究组 & 干预措施
Onabotulinum Toxin A
One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.
干预措施: Onabotulinum Toxin A (Drug)
Incobotulinum Toxin A
The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.
干预措施: Incobotulinum Toxin A (Drug)
结局指标
主要结局
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin
时间窗: At baseline and at 6 months
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles 1. mild facial wrinkles 2. moderate facial wrinkles 3. severe facial wrinkling
Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin
时间窗: At baseline and at 6 months
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles 1. minimal wrinkles 2. mild wrinkles 3. moderate wrinkles 4. severe wrinkles
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