연구정보 영문

A randomized, double-blind, controlled (Placebo) comparative clinical trial to evaluate the functionality and safety of swallow's nest extract for improving skin wrinkles, elasticity, moisturizing and whitening in adult women

Status Approved

  • First Submitted Date

    2021/09/01

  • Registered Date

    2021/09/09

  • Last Updated Date

    2022/10/28

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006558
    Unique Protocol ID SMCJH 2021-06
    Public/Brief Title swallow's nest extract clinical trial
    Scientific Title A randomized, double-blind, controlled (Placebo) comparative clinical trial to evaluate the functionality and safety of swallow's nest extract for improving skin wrinkles, elasticity, moisturizing and whitening in adult women
    Acronym swallow's nest extract
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SMCJH 2021-06
    Approval Date 2021-01-01
    Institutional Review Board Name Semyung University Chungju Korean Medicine Hospital Bioethics Committee
    Institutional Review Board Address 63, Sangbang 4-gil, Chungju-si, Chungcheongbuk-do
    Institutional Review Board Telephone 043-841-1738
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kim Ea Hwa
    Title professor
    Telephone +82-43-279-8310
    Affiliation Semyung University
    Address 65, Semyung-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea, Zip code 27136
    Contact Person for Public Queries
    Name Kim hyungmook
    Title general manager
    Telephone +82-43-279-8300
    Affiliation Semyung University
    Address 65, Semyung-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea, Zip code 27136
    Contact Person for Updating Information
    Name Shin Seon Mi
    Title professor
    Telephone +82-43-649-1873
    Affiliation Semyung University
    Address 65, Semyung-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea, Zip code 27136
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2021-01-04 Actual
    Target Number of Participant 104
    Primary Completion Date 2021-08-01 , Actual
    Study Completion Date 2021-08-17 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Semyung University
    Recruitment Status Completed
    Date of First Enrollment 2021-01-04 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Daehan Chemtech
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Semyung University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Randomized to prove superiority over control food (Placebo) and to confirm safety in skin wrinkle, elasticity, moisturizing and whitening improvement effects after consuming swallow's nest extract for 12 weeks in adult women aged 40 to less than 60 years old Assignment, double-blind, and control (Placebo) comparative  clinical trials
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Others
    (Evaluation of functional and safety improvement of skin health (wrinkle, elasticity, moisturizing, whitening) when "Swallow's nest extract" was consumed for 12 weeks in adult female subjects)
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    The main ingredient name is swallow's nest extract (22.22% of swallow's nest extract, 74.78% of maltodextrin, 1.50% of magnesium stearate, 1.50% of silicon dioxide). Usage and dosage: Take 1 capsule once a day with plenty of water before breakfast, and store at room temperature away from direct sunlight.
    
    The control is crystalline cellulose (22.22% crystalline cellulose, 74.78% maltodextrin, 1.50% magnesium stearate, 1.50% silicon dioxide), and the appearance and formulation are capsules, and the main ingredient content is 100 mg. Usage and dosage: Take 1 capsule once a day with plenty of water before breakfast, and store it at room temperature away from direct sunlight.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    52

    Arm Type

    Experimental

    Arm Description

    The main ingredient name is swallow's nest extract (22.22% of swallow's nest extract, 74.78% of maltodextrin, 1.50% of magnesium stearate, 1.50% of silicon dioxide). Usage and dosage: Take 1 capsule once a day with plenty of water before breakfast, and store at room temperature away from direct sunlight.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    52

    Arm Type

    Placebo comparator

    Arm Description

    The control is crystalline cellulose (22.22% crystalline cellulose, 74.78% maltodextrin, 1.50% magnesium stearate, 1.50% silicon dioxide), and the appearance and formulation are capsules, and the main ingredient content is 100 mg. Usage and dosage: Take 1 capsule once a day with plenty of water before breakfast, and store it at room temperature away from direct sunlight.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (L00-L99)Diseases of the skin and subcutaneous tissue 
       (L98.7)Excessive and redundant skin and subcutaneous tissue 

    adult female
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    40Year~60Year

    Description

    1) Adult women aged 40 or more and less than 60 years of age
    2) Subjects with wrinkles around the eyes and a global photo damage score of 2-6
    3) Subjects who are not currently taking health functional foods or similar products for the purpose of improving skin health such as skin wrinkles, elasticity, moisturizing, and whitening
    4) Subjects who have understood the purpose, contents, and possible adverse reactions of the study and have voluntarily signed a written consent
    Exclusion Criteria
    1) Subjects with severe acute kidney disease, heart disease, liver disease, or other chronic disease that may affect the test results within the last 6 months
    2) Subjects with a history of stroke or transient ischemic heart attack
    3) Subjects with a history of malignancy or lung disease within 5 years of screening
    4) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of rest) or uncontrolled diabetes patients (fasting blood sugar greater than 180 mg/dL)
    5) Subjects with an important neurological or psychological history or currently suffering from diseases (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
    6) Subjects with skin abnormalities such as spots, acne, tattoos, scars, erythema, capillary dilatation, and burn marks on the measurement site
    7) Subjects who have used oral or applied retinoids/steroids within 6 months prior to the start of the test, or who have undergone skin peeling or skin wrinkle removal procedures
    8) Subjects who have used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), highly moisturizing/elastic cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of screening
    9) Subjects with eczematous skin diseases (eczema, atopic dermatitis, etc.) or infectious skin diseases
    10) Subjects with allergic specific constitution (food, pollen, etc.) or hypersensitivity
    11) Subjects with irritation or allergy to cosmetics, pharmaceuticals, health functional foods, and daily exposure to sunlight
    12) Subjects with a history of hypersensitivity (allergy) to swallow's nest extract
    13) Pregnant women, lactating women, those planning to become pregnant, and those taking contraceptives or female hormones
    14) Subjects receiving other prohibited treatment (insulin, antidepressant, antiserotonin, barbiturate, antipsychotic, drug with potential for abuse, absorption inhibitor, appetite suppressant, etc.)
    15) Subjects who have used steroid-containing skin external agents for 2 weeks or more for the treatment of skin diseases
    16) Subjects who have taken steroids (oral and injection), hormones, or drugs that affect absorption, distribution, metabolism, and excretion of drugs within the past 3 months and drugs that may affect the skin
    17) Subjects with abnormalities in the general opinion of the specialist as a result of blood and urine tests (AST, ALT, ALP, γ-GT, and total bilirubin levels are more than 3 times the upper limit reference value (UNL), and serum creatinine levels are the upper limit reference value (UNL)) more than twice the
    18) Subjects within 3 months of participating in the same trial
    19) Other subjects who are considered unsuitable for the study at the discretion of the principal investigator
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Change of skin wrinkle using SV700 after 12 weeks compared to baseline
    Timepoint
    Visit Week 0, Visit Week 12
    Primary Outcome(s) 2
    Outcome
    Change in skin elasticity using cutometer after 12 weeks from base
    Timepoint
    Visit Week 0, Visit Week 12
    Primary Outcome(s) 3
    Outcome
    Change of skin moisture using Corneometer after 12 weeks from baseline
    Timepoint
    Visit Week 0, Visit Week 12
    Secondary Outcome(s) 1
    Outcome
    Changes in skin wrinkles using SV700 at 4 and 8 weeks from baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
    Secondary Outcome(s) 2
    Outcome
    Changes in skin elasticity using a cutometer at 4 and 8 weeks from baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
    Secondary Outcome(s) 3
    Outcome
    Changes in skin moisture using Corneometer at 4 and 8 weeks from baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
    Secondary Outcome(s) 4
    Outcome
    Changes in the amount of transdermal water loss using Tewameter at 4 weeks, 8 weeks, and 12 weeks from the baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
    Secondary Outcome(s) 5
    Outcome
    Changes in melanin index and erythema index using Mexameter at 4, 8, and 12 weeks from baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
    Secondary Outcome(s) 6
    Outcome
    Changes in the visual evaluation of skin wrinkles by experts at 4, 8, and 12 weeks from the baseline
    Timepoint
    Visit Week 0, Visit Week 4, Visit Week 8
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No

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