Condition category
Skin and Connective Tissue Diseases
Date applied
28/09/2020
Date assigned
05/10/2020
Last edited
05/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 January 2022

Who is funding the study?
Danisco Sweeteners Oy (Finland)

Who is the main contact?
Dr Ja Hyun Ryu, dermapro@dermapro.co.kr

Trial website

Contact information

Type

Public

Primary contact

Dr Ja Hyun Ryu

ORCID ID

Contact details

DERMAPRO Ltd.
4F
30
BangbaeJungang-ro
Seocho-gu
Seoul
06684
Korea
South
+82 2 597 5435
dermapro@dermapro.co.kr

Type

Scientific

Additional contact

Ms Laura Huuskonen

ORCID ID

Contact details

Danisco Sweeteners Oy
Sokeritehtaantie 20
Kantvik
02460
Finland
+358 40 169 4747
laura.huuskonen@dupont.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NH-10010

Study information

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

Acronym

RM_StructProb-A

Study hypothesis

Consumption of a Bifidobacterium-based probiotic reduces skin wrinkles and enhances skin hydration in adult women.

Ethics approval

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

Study design

Randomized double-blind parallel placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

1. Skin wrinkles around crow’s feet measured with PRIMOS® imaging technology at baseline and 4, 8 and 12 weeks.
2. Skin hydration measured at cheek, forearm and back of hand with corneometer and moisturemeter at baseline and 4, 8 and 12 weeks.

Secondary outcome measures

1. Transepidermal water loss from cheek, forearm and back of hand measured using evaporimeter at baseline and 4, 8 and 12 weeks
2. Cheek skin elasticity measured using cutometer at baseline and 4, 8 and 12 weeks
3. Cheek skin gloss measured using SkinGlossMeter at baseline and 4, 8 and 12 weeks
4. Body composition measured with Inbody 330 analyzer at baseline and 2 weeks
5. Facial image measured using VISIA-CR® skin analysis system at baseline and 4, 8 and 12 weeks
6. Participant's impression of product efficacy assessed using an efficacy questionnaire at 4, 8 and 12 weeks
7. Participant's impression of product usability assessed using a usability questionnaire at at 12 weeks

Overall trial start date

19/09/2019

Overall trial end date

15/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

170 (85 in test group and 85 in placebo group)

Participant 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

Recruitment start date

06/10/2020

Recruitment end date

18/12/2020

Locations

Countries of recruitment

Korea, South

Trial participating centre

DERMAPRO Ltd.
4F, 30, BangbaeJungang-ro Seocho-gu
Seoul
06684
Korea, South

Sponsor information

Organisation

Danisco Sweeteners Oy

Sponsor details

Sokeritehtaantie 20
Kantvik
02460
Finland
+358 10 431 2235
alvin.ibarra@dupont.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Danisco Sweeteners Oy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
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.

Intention to publish date

31/12/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2020: Trial's existence confirmed by Dermapro Institutional Review Board.