Effect of oral probiotics on skin wrinkles and hydration in adult women
| ISRCTN | ISRCTN10242790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10242790 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NH-10010 |
| Sponsor | Danisco Sweeteners Oy |
| Funder | Danisco Sweeteners Oy |
- Submission date
- 28/09/2020
- Registration date
- 05/10/2020
- Last edited
- 09/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Bifidobacteria are bacteria that live in the human gut. They help to improve digestion of food and suppress the growth of harmful bacteria. Gut bacteria may also have other positive effects on human heath. Bifidobacteria and components derived from Bifidobacteria have been studied for their properties in enhancing skin hydration and structure. The aim of this study is to examine the effects of taking Bifidobacterium by mouth on the skin, including wrinkles, dryness and elasticity.
Who can participate?
Korean women aged 30-60 years
What does the study involve?
Participants will be randomly allocated to one of two groups. Both groups will take a capsule by mouth once a day for 12 weeks. For one group, the capsule will contain Bifidobacterium. For the other, the capsule will be a dummy capsule containing no active ingredient (placebo). The capsules will look the same and neither the participants nor the researchers will know which capsule a participant is taking.
What are the possible benefits and risks of participating?
Participants may not benefit from the study as it is not known whether the test product will improve skin wrinkles or hydration. However, the study will extend the understanding of the effects of oral Bifidobacterium on skin wrinkles and hydration.
As for potential risks and disadvantages, blood sampling may cause a hematoma (bruise) or fainting, and the skin measurements and restrictions related to the measurements may cause inconvenience. The test product is not known to cause side effects. There is a small risk of possible allergy or intolerance, as for any dietary product.
Where is the study run from?
Danisco Sweeteners Oy (Finland)
When is the study starting and how long is it expected to run for?
September 2019 to March 2021
Who is funding the study?
Danisco Sweeteners Oy (Finland)
Who is the main contact?
Dr Ja Hyun Ryu, dermapro@dermapro.co.kr
Contact information
Public
DERMAPRO Ltd.
4F, 30, BangbaeJungang-ro
Seocho-gu
Seoul
06684
Korea, South
| Phone | +82 2 597 5435 |
|---|---|
| dermapro@dermapro.co.kr |
Scientific
Danisco Sweeteners Oy
Sokeritehtaantie 20
Kantvik
02460
Finland
| Phone | +358 40 169 4747 |
|---|---|
| laura.huuskonen@iff.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized double-blind parallel placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of Bifidobacterium on skin wrinkle, hydration, ransepidermal water loss (TEWL), elasticity and gloss: a randomized, double-blind, placebo controlled, parallel clinical trial |
| Study acronym | RM_StructProb-A |
| Study objectives | Consumption of a Bifidobacterium-based probiotic reduces skin wrinkles and enhances skin hydration in adult women. |
| Ethics approval(s) | Approved 06/08/2020, DERMAPRO Ltd. Institutional Review Board (4F, 30, BangbaeJungang-ro, Seocho-gu, Seoul, Korea; +82-2-597-5435; dermapro@dermapro.co.kr), ref: 1-220777-A-N-01-DICN20181 |
| Health condition(s) or problem(s) studied | Skin wrinkles and dry skin |
| Intervention | Participants are randomly allocated to one of two treatment groups in equal proportions applying block randomization. They receive 1 daily capsule of test product (Bifidobacterium in microcrystalline cellulose) or placebo (microcrystalline cellulose) for 12 weeks with follow-up visits at 4, 8 and 12 weeks. During the study participants will need to follow some lifestyle restrictions to allow reliable measurements of the selected skin properties. These restrictions include consumption of probiotics, use of certain topical products and exposure to excessive sunlight. The study includes 5 visits to the study clinic. All visits will be carried out at DERMAPRO Ltd., Seoul, Korea. Before each visit, make-up needs to be avoided to assure reliable measurement results. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Skin wrinkles around crow’s feet measured with PRIMOS® imaging technology at baseline and 4, 8 and 12 weeks. |
| Key secondary outcome measure(s) |
1. Transepidermal water loss from cheek, forearm and back of hand measured using evaporimeter at baseline and 4, 8 and 12 weeks |
| Completion date | 15/03/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 60 Years |
| Sex | Female |
| Target sample size at registration | 170 |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Korean female subjects aged between 30 and 60 years. 2. Dry skin on cheek (hydration value is below 48 arbirary units [AU] by Corneometer®) 3. Skin wrinkles of over grade 3 by DERMAPRO standard photograph 4. No chronic or acute disease, including skin disease 5. Signed informed consent for the study. 6. Cooperative and available for follow-up during the study period |
| Key exclusion criteria | 1. Has consumed probiotics as dietary supplements, food or beverage products during the last 2 weeks 2. Pregnant, nursing or planning to become pregnant 3. Irritation or symptomatic allergy to food, including ingredients of cosmetic, medical and test products 4. Has taken oral or topical antibiotics during the previous 3 months 5. Has taken oral retinoid/steroid drugs or topical applications including steroids during previous 6 months 6. Has used functional cosmetics for improvement of skin wrinkle, hydration and elasticity within the last 3 months 7. Previous interventions at test site (e.g. skin decortications, Botox and other skin treatments) 8. Has participated in a previous study without an appropriate intervening period (3 months) between studies 9. Has disease which might affect the study (e.g. cardiovascular, kidney, liver, thyroid, gastrointestinal disease, gout) 10. Any skin disease (e.g. atopic dermatitis) at test site 11. Any chronic disease (e.g. diabetes, asthma, high blood-pressure) or psychiatric disorder (e.g. depression, schizophrenia, alcoholism, drug addiction) 12. Take a medicine for treatment of obesity (e.g. antidepressants, anorectics), contraceptives, hormones or diuretics 13. Take excessive alcohol (over 30 g alcohol per day) 14. Sensitive or hypersensitive skin 15. Damaged skin in or around the test area, which includes sunburn, tattoos, scars or other disfiguration on the test area 16. Has an abnormal result in screening clinical chemical analysis by medical specialist 17. Has any problem which may interfere with the aim of the study as the judgment of the principal investigator |
| Date of first enrolment | 06/10/2020 |
| Date of final enrolment | 18/12/2020 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seocho-gu
Seoul
06684
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the investigational product being a food supplement, thus there is no regulatory obligation to supply participant level data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 05/12/2024 | 09/01/2025 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN10242790_BasicResults_05Dec24.pdf
- Basic results
Editorial Notes
09/01/2025: Basic results added.
12/08/2024: The intention to publish date was changed from 31/12/2023 to 31/12/2024.
14/06/2023: The intention to publish date was changed from 30/06/2023 to 31/12/2023.
08/12/2022: The intention to publish date was changed from 31/12/2022 to 30/06/2023.
10/02/2022: The overall trial end date has been changed from 15/01/2022 to 15/03/2021 and the plain English summary updated accordingly.
16/04/2021: The scientific contact and sponsor emails were updated.
10/02/2021: The following changes were made to the trial record:
1. The scientific contact and sponsor emails were updated.
2. The total final enrolment was added.
05/10/2020: Trial's existence confirmed by Dermapro Institutional Review Board.
