NCT00734786撤回1 期
Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles. Study # CLN 08-003.
Phytotox SA1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Depth of facial wrinkles
研究概览
简要总结
The main objective of the trial is to determine whether the current topical formulation of GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application
Other evaluation criteria include: safety assessment and local tolerance, depth of facial wrinkles (video microscopy imaging).
详细描述
This is a single volunteer group study. Each volunteer will be her own control. A volunteer will receive the active product containing cream on one side of her face and will receive the placebo cream on the other side.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with no bearing-child potential or with adequate birth control method.
- •Volunteers between 30 to 60 years of age.
- •Subjects with bilateral crow's feet wrinkles.
- •Regular user of cosmetic products, willing and able to comply with the study objectives.
- •Signed informed consent.
排除标准
- •Any medical condition or any use of a medication that could modify the study results (e.g.: NSAIDs, immunosuppressant drugs, insulin...).
- •Any other significant medical condition (e.g.: diabetes mellitus, heart disease, liver disease...).
- •Any other condition that in the investigator's opinion could not be appropriate with the participation in this trial.
- •Any health condition that could affect the evaluation of study parameters.
- •Acute or chronic skin disease.
- •History of allergic reaction to cosmetic compounds.
- •Pregnancy, planned pregnancy or breast-feeding.
- •Allergy to shellfish, fish or sea product (seaweed).
- •Known or suspected hypersensitivity to any of the study product compounds.
- •Participation in another clinical trial within 30 days previous to enrolment.
- •Known or suspected alcohol or drug abuse.
结局指标
主要结局
Depth of facial wrinkles
时间窗: 24 hours
次要结局
- Local and general tolerance(1day)
研究者
研究点 (1)
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