A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults
2026年7月28日 更新者:Amazentis SA
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Anurag Singh, MD PhD
- 电话号码:+41215221274
- 邮箱:asingh@timeline.com
研究联系人备份
- 姓名:Brad Currier, PhD
- 电话号码:+41215221274
- 邮箱:bcurrier@timeline.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
- Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
- Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
- Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
- Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
- Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
- Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
- Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
- Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist.
- Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms).
- Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
- Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- Trial participants willing to abide by and comply with study protocol.
Exclusion Criteria:
- Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
- Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
- Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
- Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
- Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
- Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
- Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening.
- Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products).
- Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site.
- Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
- Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
- Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
- Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse.
- Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
- Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Food supplement placebo
|
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
|
|
有源比较器:Food supplement Active
|
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water.
Also, a supplement placebo powder will be provided to double-mask the 2 active products
|
|
假比较器:Food supplement Comparator
|
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Skin aging hallmarks
大体时间:8 weeks
|
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
不良事件发生率
大体时间:8周
|
8周
|
|
|
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
大体时间:8 weeks
|
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
|
8 weeks
|
|
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
大体时间:8 weeks
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Dr. Mukta Sachdev, MD、MS Clinical Research Pvt. Ltd
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月4日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年8月31日
研究注册日期
首次提交
2026年7月28日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- SKIN/TLSS/2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.