IRCT20150101020514N23招募中3 期
A phase III, randomized, two armed, double-blinded, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.) for correction of moderate to severe glabellar line
Espad pharmed Company0 个研究点目标入组 146 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Men and women with 18 to 65 years old
- •Mild to moderate Glabellar Lines
- •Signing informed consent form
排除标准
- •Previous treatment in the glabellar area within 12 months prior to randomization
- •History of facial plastic surgery, eyebrow lift and dermal resurfacing
- •History of inserting non-absorbent substances or surgery to remove the glabellar muscle.
- •Severe atrophy in glabellar area
- •Planned Facial Cosmetic Surgery (such as filler injection, chemical peeling and laser) Using products that cause skin remodeling or active changes on the forehead area and History of any cosmetic surgery in glabellar area in the last 6 months
- •Active infection in injection area
- •Facial expressions that can impair safety or efficacy outcomes.
- •Neuromuscular connectivity disorders
- •Current treatment with drugs that interfere with neuromuscular function.
- •Allergies to botulinum neurotoxin as well as injectable fillers in the facial area
- •Participate in another research study on botulinum neurotoxin products and fillers in the last 6 months
- •Any other condition that may expose a risk to the volunteer during the study or disrupt safety or efficacy outcomes
- •Pregnancy/ breast feeding
- •History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
研究者
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