Skin wrinkles and dry skin Skin and Connective Tissue Diseases
Conditions
Interventions
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
Sponsors
Danisco Sweeteners Oy
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, South
Contacts
Public ContactJa Hyun Ryu
Outcome results
None listed