Skip to content

Efficacy and Safety of Elastin of bonito on the skin wrinkle improvement and moisturizing; Placebo-Clinical trial

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Elastin of bonito on the Skin Wrinkle Improvement and Moisturizing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007453
Enrollment
100
Registered
2022-06-29
Start date
2020-11-23
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : For a total of 12 weeks, test food (sweetfish elastin) is taken once a day, one capsule oral, and placebo with the same shape and characteristics is taken in the same way during t

Sponsors

Global Medical Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: men and women over 35 and under 60 In the visual evaluation, a person whose eye wrinkles are Grade 3 or higher on both the left and right sides Those with a water retention of 49 AU or less in both cheeks as measured by Corneometer® at visits 1 and 2 A person who has consented to participate in this human application test before the start of the human application test and filled out the Informed Consent Form Those who are currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease or malignancy People with mental disorders such as schizophrenia, depression, drug addiction, alcohol use/induced disorder, etc. Those with skin diseases such as atopic dermatitis and psoriasis Those with skin abnormalities such as spots, acne, erythema, and capillary dilatation at the test site Smokers or those who have quit smoking for less than 1 year Those who have undergone facial procedures such as botox or fillers within 6 months of visit 1, or who have undergone facial skin dermabrasion or other skin care within 1 month (30 days) Those who have used steroid-containing skin external agents on the face or oral retinoids/steroids within 3 months of visit 1 Those who have taken anti-obesity drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives or hormones, or diuretics within 1 month of visit 1 Medicines and health functional foods for skin wrinkle improvement and moisturizing effect within 2 weeks of visit 1 (health functional foods containing antioxidants, hyaluronic acid, collagen, evening primrose oil, vitamins A, C, E containing medicines and health functional foods, etc.) ) ingested Those who have used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1. Those with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more Those with a creatinine of 2.4 mg/dL or higher Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement standard after 10 minutes of rest for human subjects) Patients with uncontrolled diabetes mellitus (fasting blood sugar >180 mg/dL) Those who are pregnant, lactating, or planning to become pregnant during this human application test period Those who have participated in other interventional clinical trials (including human trials) within 1 month of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial Those who are sensitive to or allergic to the food ingredients for this human application test Those who are judged inappropriate by the investigator for other reasons

Exclusion criteria

Exclusion criteria: Those who are currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease or malignancy People with mental disorders such as schizophrenia, depression, drug addiction, alcohol use/induced disorder, etc. Those with skin diseases such as atopic dermatitis and psoriasis Those with skin abnormalities such as spots, acne, erythema, and capillary dilatation at the test site Smokers or those who have quit smoking for less than 1 year Those who have undergone facial procedures such as botox or fillers within 6 months of visit 1, or who have undergone facial skin dermabrasion or other skin care within 1 month (30 days) Those who have used steroid-containing skin external agents on the face or oral retinoids/steroids within 3 months of visit 1 Those who have taken anti-obesity drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives or hormones, or diuretics within 1 month of visit 1 Medicines and health functional foods for skin wrinkle improvement and moisturizing effect within 2 weeks of visit 1 (health functional foods containing antioxidants, hyaluronic acid, collagen, evening primrose oil, vitamins A, C, E containing medicines and health functional foods, etc.) ) ingested Those who have used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1. Those with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more Creatinine of 2.4 mg/dL or higher Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement standard after 10 minutes of rest for human subjects) Patients with uncontrolled diabetes mellitus (fasting blood sugar >180 mg/dL) Those who are pregnant, lactating, or planning to become pregnant during this human application test period Those who have participated in other interventional clinical trials (including human trials) within 1 month of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial Those who are sensitive to or allergic to the food ingredients for this human application test Those who are judged inappropriate by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
skin wrinkles; skin moisture

Secondary

MeasureTime frame
transdermal water loss; skin elasticity; Whitening;Eye Wrinkle Volume;Evaluation of the improvement of the tester in the human application test;Evaluation of improvement of subjects in human application test

Countries

Korea, Republic of

Contacts

Public Contactminok kim

Global Medical Research Center

kmo@gmrc.co.kr+82-70-4910-3040

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026