A Randomized, Double Blind, Placebo Controlled, Three Arm Clinical Study to Evaluate the Safety and Efficacy of Lutein Extract in Improving Skin Health in Healthy Male or Female Volunteers.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Change in Skin hydration from baseline to visit 3 (Week 6) and visit 4
研究概览
简要总结
Skin health is not only significantly affected by aging, but also by other lifestyle-related factors, such as sun exposure, exercise and eating habits, smoking or alcohol intake. It is known that the cutaneous tissue can exhibit visible signs of senescence, such as dull complexion, loss of firmness, or changes in pigmentation.
Exposure to solar radiation is one of the m ain factors that contribute to skin aging, since ultraviolet (UV) radiation stimulates the formation of free radicals, which can cause oxidative stress. Oxidative stress in the skin is related to mutations and photoaging. Photoaging is an accumulative process and dependents on the rate and frequency of sun exposure, as well as skin phototype (skin pigmentation). UVA radiation can penetrate through the epidermis to the dermis, causing damage to the connective tissue, or extracellular matrix (ECM), represented here by collagen, elastin and glycosaminoglycan (GAGs). Damage to these structures generates visible damage in the skin, such as loss of elasticity, hydration and skin firmness, resulting in the appearance of wrinkles and increased fragility
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory, male and female subjects of 40-60 years’ age with a Body Mass Index (BMI) of 20 to 29 kg/m
- •Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening.
- •Subjects who are having 3-5 degrees wrinkles in the crow’s-feet area, with global photodamage score between 3 and 6, and water content 170 or less on both left and right cheeks.
- •Fitzpatrick Skin Phototypes III to V
- •Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
- •Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
排除标准
- •Expectation of any surgery during the study period.
- •Subject with history of allergies to cosmetics pharmaceutical products or foods containing ingredients included in the study supplement.
- •Use of topical retinoids, any other anti-wrinkle steroid products and cosmetic products containing AHA BHA within the 3 months prior to initiation of the study.
- •Subjects who are using moisture-rich cosmetic products within the 2 Weeks prior to study initiation.
- •Subjects with uncontrolled Diabetes FPG greater than 126 mgdL and Hypertension Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg.
- •Subjects with history of renal or liver impairment, any endocrine, inflammatory cardiovascular gastro-intestinal neurological psychiatric neoplastic or metabolic disease.
- •Subjects suffering from COPD or having history of any respiratory or breathing disorders.
- •Subjects with HIV Positive status.
- •Alcohol intake more than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine marijuana etc.
- •and smokers.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •Clinically significant or abnormal laboratory results during screening.
- •Female subjects who are pregnant, breast feeding or planning to become pregnant during the study period.
结局指标
主要结局
1.Change in Skin hydration from baseline to visit 3 (Week 6) and visit 4
时间窗: Day 0, Day 42, Day 84
(Week 12).
时间窗: Day 0, Day 42, Day 84
2.Change in Elasticity from baseline to visit 3 (Week 6) and visit 4 (Week
时间窗: Day 0, Day 42, Day 84
12).
时间窗: Day 0, Day 42, Day 84
3.Change in Trans epidermal water loss (TEWL) from baseline to visit 3
时间窗: Day 0, Day 42, Day 84
7.Change in Serum Lutein and Zeaxanthin levels from baseline to visit
时间窗: Day 0, Day 42, Day 84
(Week 6) and visit 4 (Week 12).
时间窗: Day 0, Day 42, Day 84
4.Change Erythema index (EI) and melanin index (MI) from baseline to visit 3 (Week 6) and visit 4 (Week 12).
时间窗: Day 0, Day 42, Day 84
5.Change in Skin collagen measurement from baseline to visit 3 (Week 6)
时间窗: Day 0, Day 42, Day 84
and visit 4(Week 12).
时间窗: Day 0, Day 42, Day 84
6.Change in Serum Antioxidant levels (SOD & CAT) from baseline to
时间窗: Day 0, Day 42, Day 84
visit 3 (Week 6) and visit 4(Week 12).
时间窗: Day 0, Day 42, Day 84
4 (week 12).
时间窗: Day 0, Day 42, Day 84
8.Change in Skin Keratinocytes from baseline to visit 4 (week 12).
时间窗: Day 0, Day 42, Day 84
次要结局
- 1.Change in Ceramide, Fibrillin and GSH from baseline to visit 3 (Week(6) and visit 4 (Week 12).)