Effect of oral probiotics on skin hydration in adults during 12 weeks

Not Applicable

Completed

• Conditions: Dry skin; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN10965433
• Lead Sponsor: Danisco Sweeteners Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Study Completion: 2021-05-25
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Consent to participate in the study and willing to comply with the protocol and study restrictions
2. Females and males aged 20-65 years at randomization
3. Corneometer confirmed dry skin, arbitrary unit value under 45, measured from cheek, neck and anterior forearm. A series of 6 measurements will be taken and the middle 4 values will be used to calculate the mean value, which will be expressed in arbitrary units (a.u.). All 6 values from each location will be recorded.
4. Dry skin by self-assessment
5. Females of childbearing potential to follow a medically approved contraceptive method

Exclusion Criteria

1. Participation in any other clinical trial within the past 2 months before the randomization or planning to do so during the study
2. Unable or unwilling to comply with study procedures
3. Allergy or intolerance to any ingredient in the investigational products
4. Currently diagnosed with atopic dermatitis (AD)
5. Current or planned use of corticosteroids, retinoids or UV-treatment
6. Use of systemic steroids or systemic antibiotics in the 6 months before randomization
7. Use of topical corticosteroids or antibiotics prescribed by a physician or as OTC products in the 2 months before randomization
8. Wounds, scars (including severe acne scars and large burn scars) or tattoos at the skin sites to be examined in this study
9. History of any cosmetic medical treatment (such as medical chemical- or laser peelings or injections of Botox). Non-cosmetic treatment is not an exclusion criterion unless at site of measurement.
10. History of any cosmetic/beauty treatments (such as photofacial or injections of hyaluronic acid, or collagen) at the sites to be examined in this study in the past one year or intention to receive such during the study
11. Exposure to UV light treatment (such as solarium) or extensive sun bathing (i.e. skin has reacted to sun bathing) in the past two months before randomization or intention of such during the study
12. Screening hematology, serum and urinary laboratory analyses results that are deemed clinically significantly abnormal by the investigator
13. Pregnant or breastfeeding or planning pregnancy during the study
14. Otherwise considered unsuitable for the study by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified