A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 40
- 主要终点
- Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
研究概览
简要总结
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe glabellar wrinkles (frown lines)
排除标准
- •Previous treatment with botulinum toxin therapy of any serotype
- •Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
- •Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
- •Mid-facial or periorbital treatment with non-permanent soft tissue fillers
- •Subjects planning a facial cosmetic procedure or visible scars
- •Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- •Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- •History of facial nerve palsy
- •A planned extended absence during the study
研究组 & 干预措施
botulinum toxin Type A
Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
干预措施: botulinum toxin Type A (Biological)
placebo (Normal Saline)
Normal Saline (placebo) injected into the glabellar region on Day 0.
干预措施: normal saline (placebo) (Drug)
结局指标
主要结局
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
时间窗: Day 30
Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.
次要结局
- Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30(Day 30)
- Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60(Day 60)