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Effect of oral probiotics on skin wrinkle and hydration in adult women

Effects of Bifidobacterium on skin wrinkle, hydration, transepidermal water loss, elasticity and gloss: a randomized, double-blind, placebo-controlled, and parallel clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10924200
Enrollment
170
Registered
2020-10-22
Start date
2020-10-26
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Skin wrinkles and dry skin Skin and Connective Tissue Diseases

Interventions

Participants are randomly allocated to one of two treatment groups in equal proportions applying block randomization. Participants take one daily capsule of the test product (Bifidobacterium in microc

Sponsors

Danisco Sweeteners Oy
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Korean female subjects aged between 30 and 60 2. Dry skin on their cheek (hydration value is below 48 A.U. by Corneometer®) 3. Skin wrinkles over grade 3 by DERMAPRO standard photograph 4. No chronic or acute disease including skin disease 5. Signed informed consent 6. Cooperative and available for follow-up during the study period

Exclusion criteria

Exclusion criteria: 1. 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 for food including ingredients of cosmetic, medical and test product. 4. Took oral or topical antibiotics during the previous 3 months 5. Took oral retinoid/steroid drug or topical application included steroid during previous 6 months 6. Use functional cosmetics for improvement of skin wrinkle, hydration and elasticity within 3 months 7. Have an experience on the test site (skin decortications, botox and other skin treatment) 8. Participated in a previous study without an appropriate intervening period (3 months) between studies 9. Have a disease which affects the study (e.g. cardiovascular, kidney, liver, thyroid, gastrointestinal disease, gout) 10. Any skin disease (e.g. atopic dermatitis) at the 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 the treatment of obesity (e.g. antidepressants, anorectics), contraceptives, hormones or diuretics 13. Drink 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. Abnormal result in screening clinical chemical analysis by medical specialist 17. Problem which may interfere with the aim of the study as judged by the principal investigator

Design outcomes

Primary

MeasureTime frame
1. Skin wrinkles measured with PRIMOS® premium from Crow’s feet at 4, 8 and 12 weeks 2. Skin hydration measured from cheek, forearm and back of hand with corneometer and moisturemeter at baseline, 4, 8 and 12 weeks

Secondary

MeasureTime frame
1. Transepidermal water loss measured with evaporimeter from cheek, forearm and back of hand at baseline, 4, 8 and 12 weeks 2. Skin elasticity measured with cutometer from cheek at baseline, 4, 8 and 12 weeks 3. Skin gloss measured with SkinGlossMeter from cheek at baseline, 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. Product efficacy assessed using an efficacy questionnaire at 4, 8 and 12 weeks 7. Product usability assessed using a usability questionnaire at 12 weeks

Countries

Korea, South

Contacts

Public ContactRyu Ja Hyun
dermapro@dermapro.co.kr+82 (0)2 597 5415

Outcome results

None listed

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