KCT0009064已完成Unknown
A 12-Week, Randomized, Parallel, Double-blind, Placebo-controlled clinical study of rose petals extract to assess skin health improvement and safety evaluation
ovawells0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Men and women aged 25 to 65 with 3 grade to 7 grade (reflects Marie DM SOP) in wrinkles and skin color around the eyes and 49 A.U. or less (reflects C+K reference) in the cheek area
- •2) A healthy person with no acute, chronic physical illness, including skin disease
- •3) A person who voluntarily prepared and signed a consent form to participate in the clinical trial after hearing sufficient explanation from the researcher about the purpose, content, possible adverse reactions, etc. of the study
- •4) A person who can follow up during the study period
排除标准
- •1) A person who has a skin disease or has a specific allergic reaction to a raw material similar to a clinical trial product
- •2) A person who has used oral and skin external preparations containing steroids or retinoids within 24 weeks of screening
- •3) A person who participated in similar clinical tirals and the same study within 24 weeks of screening
- •4) A person with skin abnormalities such as spots, acne, erythema, capillary dilatation, etc. on the test site
- •5) A person who has used cosmetics or medicines of the same or similar ingredients on the test site within 12 weeks of screening
- •6) Those who have taken medicines and herbal medicines that can affect test results within 12 weeks of screening (hormone preparations, oral contraceptives, diuretics, acne treatments, hair loss drugs, allergies) Rhinitis therapeutic agents (Fexo-genadine components such as alicresin and allegra) and ACE inhibitor (angiotensin converting enzyme inhibitor) among high blood pressure drugs
- •7) A person who has continuously consumed health functional foods and general foods that can affect the test results within 12 weeks of screening (Health functional foods or general foods containing similar ingredients to this test material, protein-containing foods, collagen-containing products, hyaluronic acid, biotin, beer yeast, skin lactic acid bacteria, hydrangea leaf hot water extract powder, aloe gel, konjac potato extract, pomegranate-containing products, Vitamin C, ceramide, gamma-linolenic acid, Yang placenta, N-acetylglucosamine, noni fruit, chlorella, spirulina, etc.)
- •8) Test within 24 weeks of screening timeA person who has undergone treatment (skin dermabrasion, Botox, laser, other skincare, etc.) on the area
- •9) A person who plans to become pregnant, is pregnant, or is breastfeeding within 24 weeks of screening
- •10) Those who have experienced drug-sensitive (hyperactive) or allergic reactions
- •11) People with uncontrolled hypertension or diabetes (excluding those who take drugs with NO synthetic metastasis among high blood pressure drugs)
- •12) Those with clinically significant diseases (cardiovascular, dyslipidemia, endocrine, digestive, urinary diseases, neuropsychiatric diseases, and malignant tumors) that require treatment (but can participate if they have not recurred for more than 5 years after surgery)
- •13) A smoker or a person who has quit smoking for less than one year
- •14) In diagnostic test medical examination, the followinga person who results in
- •- AST, ALT > three times of reference range
- •- Serum Creatinine > 2.0 mg/dl
- •15) A person who is in charge of testing is deemed unsuitable for participation in research due to the results of diagnostic test medical examination and other reasons
研究者
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