NCT05217355已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Medytox Korea1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Facial Wrinkle Scale(FWS) change
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 19 and 65
- •Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- •Patients who voluntarily sign the informed consent
排除标准
- •Patients with the history of facial nerve paralysis
- •Patients with the symptoms of eyelid ptosis determined by the investigator
- •Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin, or the inability to substantially lessen glabellar lines even by physically spreading them apart, as determined by the investigator
- •Active skin disease or infection in the treatment area
- •History of surgery which may habe altered the anatomy of the corrugator supercilia muscle or the procerus muscle or related nerve
- •Prior treatment with permanent filers, synthetic implantation, and/or autologous fat transplantation in the treatment area
- •Subject who received the following drugs within 4 weeks prior to the screening
- •muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants
- •benzodiazepine: Diazepam, Chlodiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Lorazepam etc.
- •Subject who takes Muscle relaxants and benzodiazepine stably for 4 weeks can participate the study
- •Subject who reveived any of the below facial aesthetic treatments that, in the investigator's opinion, could interfere the evaluation of efficacy
- •Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.)
- •Facial resurfacing or skin tightening procedure with lase, light or radiofrequency-based system; or any medium depth or deep depth facial chemical peels in the upper face within 6 months prior to screening
- •Subject who received Retinois following period
- •Systemic drug delivery : within 6 months prior to the screening
- •Local drug delivery : within 3 months prior to the screening
- •Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- •Known immunization or hypersensitivity to any botulinum toxin preparations
- •Subject who had botulinum toxin treatment within 6 months prior to the screening or planning to receive botulinum toxic treatment during the study period other than study treatment
- •Female subjects who are pregnant or nursing, or planning a pregnancy during the study and female subjects of childbearing potential who are not willing to use acceptable form of sontraception
- •Subject who are participating in other interventional clinical study or have participated in such a study within 30 dyas prior to screening
- •Subjects who are not eligible for this study at the discretion of the investigator
研究组 & 干预措施
MBA-P01
Experimental
Experimental group, Dose: 20U
干预措施: MBA-P01 (Botulinum toxin A) (Drug)
Placebo
Placebo Comparator
Placebo gorup, Normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Facial Wrinkle Scale(FWS) change
时间窗: 4 weeks
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
次要结局
- Investigator-rated improvement rate of glabellar lines at maximum frown(Week 8, 12, 16)
- Investigator-rated improvement rate of glabellar lines at rest(Week 4, 8, 12, 16)
- Participant-rated improvement rate of glabellar lines at maximum frown(Week 4, 8, 12, 16)
- Participant-rated improvement rate of glabellar lines at rest(Week 4, 8, 12, 16)
- Participant-rated satisfaction after treatment(Week 4, 8, 12, 16)
研究者
研究点 (1)
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