Status Approved
First Submitted Date
2021/09/01
Registered Date
2021/09/09
Last Updated Date
2022/10/28
1. Background
CRIS Registration Number |
KCT0006558 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Daehan Chemtech |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Semyung University |
Organization Type | University |
7. Study Summary
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 |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (L00-L99)Diseases of the skin and subcutaneous tissue (L98.7)Excessive and redundant skin and subcutaneous tissue adult female |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Change of skin wrinkle using SV700 after 12 weeks compared to baseline |
|
Timepoint | Visit Week 0, Visit Week 12 |
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Primary Outcome(s) 2 | ||
Outcome | Change in skin elasticity using cutometer after 12 weeks from base |
|
Timepoint | Visit Week 0, Visit Week 12 |
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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 |
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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 |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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