Status Approved
First Submitted Date
2020/10/27
Registered Date
2020/11/03
Last Updated Date
2020/12/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005565 |
|---|---|
| Unique Protocol ID | 제1-220777-A-N-01호-DICN20182 |
| Public/Brief Title | Effects of Bifidobacterium on Skin Wrinkle, Hydration, TEWL, Elasticity and Gloss: a randomized, double-blind, placebo controlled, and parallel clinical trial |
| Scientific Title | Effects of Bifidobacterium on Skin Wrinkle, Hydration, TEWL, Elasticity and Gloss: a randomized, double-blind, placebo controlled, and parallel clinical trial |
| Acronym | NH-10011 RM_StructProb B |
| 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 |
|---|---|
| Board Approval Number | 제1-220777-A-N-01호-DICN20182 |
| Approval Date | 2020-09-21 |
| Institutional Review Board Name | DERMAPRO Institutional Review Board |
| Institutional Review Board Address | 30, Bangbaejungang-ro, Seocho-gu, Seoul |
| Institutional Review Board Telephone | 02-597-5434 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Min Kyung Shin |
| Title | Dermatologist |
| Telephone | +82-2-597-5415 |
| Affiliation | Kyung Hee University Hospital |
| Address | 30 bangbaejungang-ro, Seocho-gu, Seoul, Rep. of Korea |
| Contact Person for Public Queries | |
| Name | Ja Hyun Ryu |
| Title | Team leader |
| Telephone | +82-70-8672-1184 |
| Affiliation | DERMAPRO |
| Address | 30 bangbaejungang-ro, Seocho-gu, Seoul, Rep. of Korea |
| Contact Person for Updating Information | |
| Name | Ja Hyun Ryu |
| Title | team leader |
| Telephone | +82-70-8672-1184 |
| Affiliation | DERMAPRO |
| Address | 30 bangbaejungang-ro, Seocho-gu, Seoul, Rep. of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-11-23 Actual | |
| Target Number of Participant | 170 | |
| Primary Completion Date | 2021-04-30 , Anticipated | |
| Study Completion Date | 2021-04-30 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | DERMAPRO | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-11-23 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Danisco Sweeteners Oy |
| Organization Type | Others |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Danisco Sweeteners Oy |
| Organization Type | Others |
7. Study Summary
| Lay Summary | To evaluate the effects of Bifidobacterium animalis ssp. lactis on skin wrinkle, hydration, transepidermal water loss (TEWL), elasticity and gloss on human skin intended following the Korean MFDS guidelines for the claim ‘Maintained skin health condition from skin damage of continuous UV expose’ (revised 2019.6). This is a proof-of concept study with a commercially available strain for skin condition related outcomes. During the course of the 12 weeks study, 8 assessments will be performed at baseline, 4, 8 and 12 weeks after start of treatment, and 2 assessments will be conducted twice, at screening and 12 weeks (chemical analysis of blood) or baseline and 12 weeks (body composition). Assessments of this study are performed after stabilization for 30 minutes under a given relative temperature (22±2℃) and humidity (50±5%) which is controlled and maintained. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Basic Science |
| Phase | Phase1/Phase2 |
| Intervention Model | Parallel |
| Blinding/Masking | Double |
| Blinded Subject | Subject, Investigator |
| Allocation | RCT |
| Intervention Type | Others |
| Intervention Description | participants will ingest one capsule of the investigational product (test or placebo) orally with still water (not sparkling) at room temperature once a day at least 15 min before breakfast time (e.g. 7 am) |
| Number of Arms | 2 |
| Arm 1 |
Arm Label Test product (Bifidobacterium) |
|
Target Number of Participant 70 |
|
|
Arm Type Experimental |
|
|
Arm Description participants will ingest one capsule of the investigational product (1.75 billion CFU) orally with still water (not sparkling) at room temperature once a day at least 15 min before breakfast time (e.g. 7 am). |
|
| Arm 2 |
Arm Label Placebo product |
|
Target Number of Participant 70 |
|
|
Arm Type Placebo comparator |
|
|
Arm Description participants will ingest one capsule of the placebo product orally with still water (not sparkling) at room temperature once a day at least 15 min before breakfast time (e.g. 7 am) |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (L00-L99)Diseases of the skin and subcutaneous tissue (L85.3)Xerosis cutis healthy Korean female subjects with dry skin and having crow's feet |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Female |
|
Age 30Year~60Year |
|
|
Description ① Korean female subjects who aged between 30 and 60 years. ② Participants who have dry skin on cheek (hydration value is below 48 A.U. by Corneometer®). ③ Participants who have skin wrinkle over 3 grade by DERMAPRO standard photograph. ④ Participants who don’t have any chronic or acute disease including skin disease. ⑤ Participants who signed and informed consent of the study. ⑥ Participants who are cooperative and available for follow-up during the study period. |
|
| Exclusion Criteria |
① Participant who have consumed probiotics as dietary supplements, food or beverage products during the last two weeks. ② Participants who are pregnant, nursing or planning to become pregnant. ③ Participants who have irritation or symptomatic allergy for food including ingredients of cosmetic, medical and test product. ④ Participants who take oral or topical antibiotics during the previous 3 months. ⑤ Participants who take oral retinoid/steroid drug or topical application included steroid during previous 6 months. ⑥ Participants who use functional cosmetics for improvement of skin wrinkle, hydration and elasticity within 3 months. ⑦ Participants who have an experience on test site (skin decortications, botox and other skin treatment). ⑧ Participants who participate in a previous study without an appropriate intervening period (three month) between studies. ⑨ Participants who have disease which affected the study (e.g. cardiovascular, kidney, liver, thyroid, gastrointestinal disease, gout). ⑩ Participants who have any skin disease (e.g. atopic dermatitis) in test site. ⑪ Participants who have any chronic disease (e.g. diabetes, asthma, high blood-pressure) or psychiatric disorder (e.g. depression, schizophrenia, alcoholism, drug addiction). ⑫ Participants who take a medicine for treatment of obesity (e.g. antidepressants, anorectics), contraceptives, hormones or diuretics ⑬ Participants who take excessive alcohol (over 30g alcohol per day). ⑭ Participants who has sensitive or hypersensitive skin. ⑮ Participants who have damaged skin in or around the test area which includes sunburn, tattoos, scars or other disfiguration on the test area. 16 Participants who have an abnormal result in screening clinical chemical analysis by medical specialist 17 Participants who have a problem which may interfere with the aim of the study as the judgment of the principal investigator. |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | skin wrinkle |
|
| Timepoint | 0,4,8,12 weeks |
|
| Primary Outcome(s) 2 | ||
| Outcome | skin hydration |
|
| Timepoint | 0,4,8,12 weeks |
|
| Secondary Outcome(s) 1 | ||
| Outcome | skin elasticity |
|
| Timepoint | 0,4,8,12 weeks |
|
| Secondary Outcome(s) 2 | ||
| Outcome | skin gloss |
|
| Timepoint | 0,4,8,12 weeks |
|
| Secondary Outcome(s) 3 | ||
| Outcome | Trans-epidermal water loss |
|
| Timepoint | 0,4,8,12 weeks |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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