NCT07517900已完成不适用
A Clinical Safety in Use Study of 30 Healthy Volunteers to Investigate the Safety of 1 Test Article Following Repeated Applications
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to investigate the safety of 1 topically applied test article containing Mitopure in a panel of healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female participants aged 18+.
- •Participant has signed a written Informed Consent.
- •Participant must agree to refrain from taking any new medications or herbal supplements during the study, unless permitted by the investigator.
- •Participant does not have grade of 3 or higher of any skin attribute per the grading scale.
- •Participant is willing to ONLY use the test article on themselves during the study as instructed and not use other facial serum products.
- •Participant is willing to attend all study visits and to follow the study instructions and prohibitions.
- •Participant must agree to refrain from using any new facial serum products, cleansers, laundry detergents, fragrances while participating in this study.
排除标准
- •Participant is pregnant, nursing, or planning to become pregnant (by verbal response only).
- •Participant has a current skin disease of any type (e.g., eczema, psoriasis, rosacea, atopic dermatitis, vitiligo).
- •Participant has a known allergy to face serum products, or the ingredients included in the test article.
- •Participant has a history of malignant disease.
- •Participant has cuts, scratches, abrasions, rashes, scarring, birthmarks, or tattoos on their face that may interfere with assessments.
- •Participant has a significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
- •Participant has a known sensitivity to the test article, similar materials, or their constituents.
- •Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
- •Medical condition that may affect study data or participant safety which in the opinion of the Investigator would compromise the safety of the participant or study results.
- •History of poor cooperation, non-compliance, or unreliability.
- •Investigator deems the participant an unsuitable candidate for the study.
研究组 & 干预措施
Mitopure Topical Formula
Experimental
干预措施: Mitopure Topical Formula (Other)
研究者
研究点 (1)
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