Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead
研究概览
简要总结
Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.
One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
详细描述
There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Subjects of any race, from 18 to 65 years old
- •Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead
- •Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential
排除标准
- •Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than:
- •Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2 weeks
- •Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes) 1 month
- •Ablative skin resurfacing
- •Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments) 6 months
- •Treatment with a BoNT-A 12 months
- •Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations) 24 months
- •Subjects who undergone a surgical facelift;
- •Permanent or semi-permanent dermal fillers in the forehead area;
- •Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
- •Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;
- •Pregnant women, nursing mothers, or women who are planning pregnancy during the study;
研究组 & 干预措施
intra-individual comparison
干预措施: Botulinum Toxin Type A - Azzalure (Drug)
intra-individual comparison
干预措施: Botulinum Toxin Type A - Vistabel (Drug)
结局指标
主要结局
Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead
时间窗: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5
Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.
次要结局
未报告次要终点