KCT0008242已完成未知
Clinical Trial to Evaluate The Effectiveness, Safety of Enzyme-Treated Caviar Powder on Wrinkle Improvement and Moisturizing Effect (Randomized, Double-blind, Placebo-controlled)
COSMAX BIO0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
- Information on study subjects 1) Number of target subjects (Unit: Person) - 50 Screening = 5 Screening dropouts + 45 **Registrations *5 Screening dropouts : 3 people who meet the criteria for exclusion from selection + 2 people who withdraw their consent ** 45 Registrations = 0 dropouts + 0 in progress + 45 completed 2) Number of subjects by gender - Test group 1 (Enzyme-Treated Caviar Extract): 12 women, 3 men - Test group 2 (Enzyme-Treated Caviar Extract + Collagen): 14 women, 1 men - Control group (Maltodextrin): 13 women, 2 men 3) Number of subjects by age - Test group 1 (Enzyme-Treated Caviar Extract): 3 in their 30s, 4 in their 40s, 7 in their 50s, 1 in their 60s (average age 48.467) - Test group 2 (Enzyme-Treated Caviar Extract + Collagen): 2 in their 30s, 6 in their 40s, 5 in their 50s, 2 in their 60s (average age 48.067 years) - Control group (Maltodextrin): 10 in their 40s, 4 in their 50s, 1 in their 60s (average age 48.067 years) 2. Information on study outcome variables 2-1. Results of primary outcomes 1) Skin Wrinkles (visual evaluation, Mark-Vu, PRIMOSCR) - In the visual evaluation, there was no significant difference between test group 1, 2 and the control group. - In the PRIMOS CR measurement, test groups 1 and 2 showed significant differences in Ra and Rz compared to the control group. In Rmax, only test group 1 showed a significant difference compared to the control group. 2) Skin Hydration - Test groups 1 and 2 showed significant differences compared to the control group. 2-2. Results of secondary outcomes 1) Skin Elasticity(R7), Evaluation of Improvement after Test Substance Ingestion by Investigators - Test groups 1 and 2 showed significant differences compared to the control group. 2) Moisture Content in Deep Skin, Skin Elasticity(R5), Transepidermal Water Loss (TEWL), Skin Melanin - Only test group 1 showed a significant difference compared to the control group. 3) Evaluation of Improvement after Test Substance Ingestion by Subjects - There was no significant difference between test group 1, 2 and the control group. 4) Safety Variables There were no significant differences between the three groups in adverse reactions and clinical Laboratory tests. 4. Summary of results In conclusion, Enzyme-Treated Caviar Extract had a significant effect on the improvement of skin elasticity, whitening, wrinkles, and hydration in this randomized, double-blind, placebo-controlled clinical trial. It has the potential to be used as an advanced raw material for supplements used to improve skin health.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 30(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Adult men and women between the ages of 30 and 65
- •2) A person with a grade of wrinkles around the eyes of Grade 3 or higher based on the Crow's feet wrinkle photo scale
- •3) A person whose cheek moisture retention was measured with Corneometer® CM825 at Visit 1 and Visit 2 and the result value was 49 A.U. (Arbitrary Unit) or less
- •4) A person who consented to participate in this clinical trial and filled out the Informed Consent Form before the clinical trial started
- •5) A person who can be followed up during the study period
排除标准
- •1) A person who is a currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary tract, kidney and urinary, nervous, musculoskeletal, infectious diseases and malignant tumors, etc.
- •2) A person with mental illness such as schizophrenia, depression, drug addiction, and alcohol use/induced disorders, etc.
- •3) A person with skin diseases such as atopic dermatitis and psoriasis,etc.
- •4) A person with skin abnormalities such as moles, acne, erythema, telangiectasia, etc. in the area to be tested
- •5) Based on visit 1, a person who has undergone facial botox or filler treatment within 6 months, or who have received facial laser treatment, skin peeling, or other skin care within 1 month (30 days)
- •6) Based on visit 1, a person who has used steroid-containing skin exfoliation agents on the facial area or have taken oral retinoid/steroid agents within 1 month
- •7) Based on visit 1, a person who has taken anti-obesity drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives, hormones, or diuretics within 1 month
- •8) Based on visit 1, a person who consumed medicines and health functional foods(Health functional food containing antioxidants, hyaluronic acid, collagen, evening primrose oil, medicines and health functional foods containing vitamins A, C, and E, etc.) for the purpose of skin wrinkle improvement and moisturizing effect within 2 weeks
- •9) Based on visit 1, a person who has used functional cosmetics for wrinkle improvement (retinoids, AHAs, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks
- •10) A person with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more
- •11) A person with creatinine of 2.4 mg/dL or higher
- •12) A person with TSH below 0.1 µIU/mL or above 10 µIU/mL
- •13) A person with uncontrolled diabetes (fasting blood sugar over 180mg/dL)
- •14) Pregnant or lactating women or those who plan to become pregnant during this human study
- •15) Based on visit 1, a person who has participated in other interventional clinical trials (including human studies) within 1 month, or plan to participate in other interventional clinical trials (including human studies) after the start of this human study
- •16) A person who is sensitive or allergic to food ingredients for this human study
- •17) A person who is judged unsuitable by the tester for other reasons
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