A Randomized, Evaluator-Blinded, Two Centre Study of the Safety and Effect of Volume on the Diffusion and Efficacy of BOTOX Cosmetic™ (Botulinum Toxin Type A) in the Treatment of Lateral Orbital Rhytides.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Using the per visit photographs, the effect of Botox was measured separately for each treatment site (right and left crow's feet at maximum smile) for all visits.
研究概览
简要总结
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.
The study was designed to test this thinking, using the crow's feet wrinkles as the treatment area.
详细描述
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.
20 female subjects (10 per site), who fit the inclusion/exclusion criteria for study participation were injected with 5 units of Botox (one injection each side) into the crow's feet area. The injections were prepared with one side randomly receiving a five fold difference in volume for dilution.
Response to treatment was evaluated at 14 days, 30 days, 60 days and 90 days after the injection visit. Standardized photography was taken at each visit.
Analysis of the photographs of the lateral orbital (crow's feet rhytides) at maximum attempted contraction (maximum smile) was done by Canfield Scientific, Inc., using a specialized software program created to detect and measure changes.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female outpatients; at least 18 years of age
- •Subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline/Screening Visit and practice a reliable method of contraception throughout the study.
- •Bilaterally symmetric moderate (score 2 on Allergan Photonumeric Guide for Crow's Feet) Lateral Orbital Rhytides at maximum smile
排除标准
- •Subjects who are pregnant, are planning a pregnancy during the study period, have an infant they are breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- •Subjects with a history of injection to the lateral orbital area with botulinum toxin type A within one year of baseline visit.
- •Subjects with a history of adverse reaction to botulinum toxin type A.
- •Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert syndrome, Amyotrophic Lateral Sclerosis, or any other disease which might interfere with neuromuscular transmission.
- •Subjects with a history of facial nerve palsy.
- •Subjects with profound atrophy or excessive weakness of muscles in the target areas for injections.
- •Subjects with a systemic infection or an infection at the injection site.
结局指标
主要结局
Using the per visit photographs, the effect of Botox was measured separately for each treatment site (right and left crow's feet at maximum smile) for all visits.
次要结局
- Using the per visit photographs, the remaining effect of Botox treatment was measured separately for each treatment site (right and left crow's feet at maximum smile) for the 30, 60, and 90 day follow up visits.