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Effects of Bifidobacterium on Skin Wrinkle, Hydration, TEWL, Elasticity and Gloss: a randomized, double-blind, placebo controlled, and parallel clinical trial

Effects of Bifidobacterium on Skin Wrinkle, Hydration, TEWL, Elasticity and Gloss: a randomized, double-blind, placebo controlled, and parallel clinical trial

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0005565
Enrollment
170
Registered
2020-11-03
Start date
2020-11-23
Completion date
Unknown
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : 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 t

Sponsors

Danisco Sweeteners Oy
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ? Korean female subjects who aged between 30 and 60 years. ? Participants who have dry skin on cheek (hydration value is below 48 A.U. by Corneometer®). ? Participants who have skin wrinkle over 3 grade by DERMAPRO standard photograph. ? Participants who don’t have any chronic or acute disease including skin disease. ? Participants who signed and informed consent of the study. ? Participants who are cooperative and available for follow-up during the study period.

Exclusion criteria

Exclusion criteria: ? Participant who have consumed probiotics as dietary supplements, food or beverage products during the last two weeks. ? Participants who are pregnant, nursing or planning to become pregnant. ? Participants who have irritation or symptomatic allergy for food including ingredients of cosmetic, medical and test product. ? Participants who take oral or topical antibiotics during the previous 3 months. ? Participants who take oral retinoid/steroid drug or topical application included steroid during previous 6 months. ? Participants who use functional cosmetics for improvement of skin wrinkle, hydration and elasticity within 3 months. ? Participants who have an experience on test site (skin decortications, botox and other skin treatment). ? Participants who participate in a previous study without an appropriate intervening period (three month) between studies. ? Participants who have disease which affected the study (e.g. cardiovascular, kidney, liver, thyroid, gastrointestinal disease, gout). ? Participants who have any skin disease (e.g. atopic dermatitis) in test site. ? Participants who have any chronic disease (e.g. diabetes, asthma, high blood-pressure) or psychiatric disorder (e.g. depression, schizophrenia, alcoholism, drug addiction). ? Participants who take a medicine for treatment of obesity (e.g. antidepressants, anorectics), contraceptives, hormones or diuretics ? Participants who take excessive alcohol (over 30g alcohol per day). ? Participants who has sensitive or hypersensitive skin. ? 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.

Design outcomes

Primary

MeasureTime frame
skin wrinkle;skin hydration

Secondary

MeasureTime frame
skin elasticity;skin gloss;Trans-epidermal water loss

Countries

Korea, Republic of

Contacts

Public ContactJa Hyun Ryu

Dermapro

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026