NCT04248699已完成不适用
Open-Label Study to Assess the Impact of Lycored's Nutritional Supplement Lumenato on Skin Parameters in Healthy Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LycoRed Ltd.
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
研究概览
简要总结
This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance.
详细描述
The purpose of this study is to evaluate perceived changes in skin health and appearance after taking the study product daily for 12 weeks. The study product is a soft gel supplement containing tomato oil. This an open-label study, meaning there is no placebo control arm for the study, and everyone enrolled in the study will receive the active study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participants with Fitzpatrick skin types of 1, 4, 5 or 6
- •Known allergies or sensitivity to tomato, latex and/or potato
- •Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
- •Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as >10 consecutive days
- •Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
- •Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
- •Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
- •Currently active herpes infections or currently on treatment for herpes infections
- •History of facial keloids
- •Current diagnosis of adult acne or currently on treatment for adult acne
- •Recent (<6 months at enrollment) cardiovascular conditions such as stroke, transient ischemic attack (TIA), or myocardial ischemia/infarction, recently on treatment for congestive heart failure, or currently having vasculitis or vascular conditions
- •On potent blood thinners such as low-molecular weight heparin (LMWH), rivaroxaban, apixaban, or other prescription blood thinners - excludes aspirin
- •Holds a current diagnosis of diabetes mellitus type I or II
- •Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study
- •Chronic liver disease- excluding early stage non-alcoholic fatty liver disease (NAFLD)
- •Chronic kidney disease or recent (<6 months at enrollment) acute kidney disease
- •Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan
- •Participants with occupations or lifestyle that require significant daily exposure to the sun (defined as at least 1 hour of continuous outdoor sun exposure)
- •Participants who have had a sunburn in the last 2 weeks
- •Participants who use tanning salons or tanning products in the last 3 months
- •Participants who plan to undergo invasive facial procedures (injections, chemical peeling, etc.) during the study or have undergone these procedures within 2 months prior to enrollment
- •Change in oral supplements or medications targeting skin health within 2 months prior to enrollment
- •Participants who are HIV positive
- •Participants who are immunosuppressed
- •Participants with a recent (<2 months prior to enrollment) diagnosis of a psychiatric condition
- •Participants having chronic connective tissue disorder affecting the skin (e.g. Ehlers- Danlos syndrome, Marfan's Syndrome, Osteogenesis Imperfecta)
- •Participants with auto-immune skin diseases (e.g. scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis)
- •Participants who have been prescribed retinoids treatment (<2 months prior to enrollment)
- •Participants who meet either/or both of the following criteria with regards to smoking habits (smoking includes cigarettes, e-cigs, pipes, hookah, cigars):
- •Who are current smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime) and who continue to use these products
- •Who were former smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime, but who have quit smoking) who have smoked within the last year and/or were former smokers for 10 years
- •Participants who drink more than 14 drinks per week (more than 2 drinks per night)
- •Participants who use illicit or illegal drugs
- •Participants who are regular users of cannabis substances or substances derived from cannabis such as CBD, CBD oils or balms, cannabis-containing edibles; vaping; smoking; hookahs.
- •NOTE: regular use is defined as long stretches of inhaling or consuming these products over several months or longer. Occasional, but not weekly, use of products with small amounts of CBD-related compounds (e.g. waters with CBD infusions) are not considered regular use.)
- •Participants who are planning a trip to the mountains or to a higher UV index region during the study period
- •Any other medication, condition or disease that in the PI's opinion that may adversely affect the participant's ability to complete the study, substantially impact the study's integrity or may pose a significant risk to the participant
- •Participants who are experiencing perimenopausal or menopausal symptoms
- •Participants who have had a hysterectomy and/or both of their ovaries removed
结局指标
主要结局
Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
时间窗: 12 weeks
FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).
次要结局
- End of Study Product Questionnaire"(12 weeks)
- Baseline Skin Questionnaire(12 weeks)
- Skin Update Questionnaire(12 weeks)
研究者
研究点 (2)
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