NCT06804772进行中（未招募）不适用
A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging, Part 2
Victoria Collotta1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年12月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9
研究概览
简要总结
A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.
- •Subject has signed a written Informed Consent prior to Day -
- •100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.
- •50% of subjects have self-perceived sensitive skin.
- •20% of the subjects are not 100% Caucasian.
排除标准
- •Subject is pregnant, nursing, or planning to become pregnant.
- •Subject is currently using medication likely to affect the response to investigational formulation.
- •Subject had a fever in the last 12 hours prior to the start of the study.
- •Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis; insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.
- •The Subject used a form of retinol on their face in the past six months.
- •The Subject used any prescription skincare products on their face in the last six months.
- •The Subject has received any laser, chemical peel, or other facial resurfacing treatment such as microdermabrasion, dermablading or microneedling in the past four weeks.
- •The Subject received Botox, Dysport, other muscle relaxers or injectable skin fillers in the face during the past six months.
- •Subject has a known allergy or sensitivity to any ingredient in the aqueous skincare formulation provided for their use in the trial .
- •Subject is currently participating in another study utilizing facial products.
- •Subject is blind, visually impaired or decisionally impaired.
研究组 & 干预措施
0 female subjects, aged 35-65, will receive Investigational Facial Serum #1
Experimental
干预措施: Investigational Facial Serum #1 (Other)
0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2
Active Comparator
干预措施: Investigational Facial Serum #2 (Other)
~15 subjects, aged 35-65, will receive Investigational Facial Serum #3
Placebo Comparator
干预措施: Investigational Facial Serum #3 (Other)
结局指标
主要结局
Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9
时间窗: Day 0 to Day 28
Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #3 at Day 28 vs. Day 0
次要结局
- Change in appearance of skin characteristics(Day 0 to Day 28)
研究者
Victoria Collotta
General Manager, Branded Products, Principal Investigator
Evolved By Nature
研究点 (1)
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