Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles.
详细描述
Argireline has mechanism of action that significantly inhibited neurotransmitter release with a potency similar to that of BoNTA. Inhibition of neurotransmitter release was due to the interference of the hexapeptide with the formation and/or stability of SNARE complex. Notably, this peptide did not exhibit in vivo oral toxicity nor primary irritation at high doses. These findings demonstrate that Argireline is a anti-wrinkle peptide that emulates the action of currently used BoNTs.
In vivo study, Topical Argireline 10% is applied on lateral preorbital area twice daily for 30 days. The result demonstrates a significant anti-wrinkle activity by decreased skin wrinkle 30%. These findings demonstrate a significant anti-wrinkle activity for Argireline, in agreement with its in vitro and cellular activities. Topical Argireline represents a bio-safe alternative to BoNTs in anti-wrinkle therapy.
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
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy woman at 35-45 years old
- •Presence of periorbital wrinkles
排除标准
- •Pregnancy
- •Keloids /scar at periorbital area
- •pre-treatment with topical periorbital products within 1 month
- •Botulinum toxin A injection,facial plastic surgery within 1 year
- •Allergic to active ingredients including acetyl hexapeptide-3 Argireline®, sodium hyaluronate,adenosine,arbutin,fucus vesiculosus)
研究组 & 干预措施
Study group
This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months.
干预措施: 10% Argireline (Drug)
结局指标
主要结局
Efficacy
时间窗: 3 months
Objective evaluation * Noninvasive measurement by skin bioengineering technique e.g. visioscan, corneometer, cutometer * Comparative photographic evaluation by certified dermatologists Subjective evaluation * Patient Self assessment satifaction review
次要结局
- Safety(3 months)