NCT07740824尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Amazentis SA
- 入组人数
- 90
- 主要终点
- Skin aging hallmarks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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.
结局指标
主要结局
Skin aging hallmarks
时间窗: 8 weeks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
次要结局
- Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)(8 weeks)
- changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.(8 weeks)
- Incidence of adverse events(8 weeks)
研究者
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