Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
研究概览
简要总结
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
详细描述
In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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 decided to receive Botox® treatment for their forehead/glabellar wrinkles
- •Has the willingness and ability to understand and provide informed consent and communicate with the investigator
- •Is willing to return for follow-up visits
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 year, 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 year
- •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
- •Is unable to understand the protocol or to give informed consent
- •Is unable to return for follow-up visits
- •Has a mental illness
研究组 & 干预措施
Muscle contractions
Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.
干预措施: Botulinum Toxin A (Procedure)
No muscle contractions
Patients will be asked to not perform muscle contractions following Botox injections.
干预措施: Botulinum Toxin A (Procedure)
结局指标
主要结局
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
时间窗: 13 months
A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.
次要结局
- Number of Participants with Adverse Events(13 months)
- Level of Satisfaction(7 months)
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University