Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058655) titled 'Examination of the effect of continuous intake of lactic acid bacteria on skin damage induced by ultraviolet (UV)' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - DRC CO., LTD.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to consider the effect of whether ingestion of test food suppress skin damage after ultraviolet (UV) radiation in healthy subjects.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take 2 tablets of test foods with water once a day for 13 weeks.
Interventions/Control_2 - Take 2 tablets of placebo foods with water once a day for 13 weeks.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Male and Female between 20 and 59 years old of age at the time of obtaining consent to participate in the study.
2.Individuals who have Fitzpatrick skin phototype 2 or 3.
3.Those whose back skin allows for the evaluation of UV-induced erythema.
4.Those whose MED is determined to correspond to the 2nd, 3rd, 4th, or 5th level in the 6-step UV irradiation performed prior to the intake of the test product.
5.Those who are able to visit the study site on all scheduled study days.
6.Those who have received sufficient explanation about the purpose and details of the study, have the capacity to consent, fully understand the study, voluntarily agree to participate, and provide written informed consent.
Key exclusion criteria - 1.Those who smoke.
2.Those who have been diagnosed with photosensitivity.
3.Those who taking drugs that may affect the photosensitivity of the skin.
4.Those who have any factors on the evaluation site that may affect the study results.
5.Those who have a history or current diagnosis of atopic dermatitis, or who have an atopic predisposition.
6.Those who have received or plan, to receive cosmetic treatment on the evaluation site during the study period.
7.Those who have received skincare treatments within 4 weeks, or plan to receive them during the study period.
8.Those who consume foods or supplements including high lactic acid bacteria or natto bacteria.
9.Those who regularly use body creams, lotions, or other skincare products on the evaluation site.
10.Those who regularly use basic skincare products or health foods containing vitamin C on the evaluation site.
11.Those who continuously use skincare products, cosmetics, quasi-drugs, or health foods.
12.Those who are continuously taking pharmaceuticals that claim efficacy for pigmentation.
13.Those who have changed or started using health foods or basic cosmetics within 4 weeks.
14.Those who expressed to UV beyond daily life within 4 weeks, or planning such exposure during the study.
15.Those who work night shifts or rotating day/night shifts.
16.Those who receiving or needing medical care for disease/prevention when consenting.
17.Those who use anti-inflammatory drugs (including pain relievers) continuously at least once per month.
18.Those who have a history of serious disorders.
19.Those who have a history of alcohol or drug dependence.
20.Those who may have allergic reactions to cosmetics or food products.
21.Those who are pregnant, breastfeeding, or intending to become pregnant during the study period.
22.Those who participated in other study within 4 weeks, or plan to participate during this study period.
23.Those deemed unsuitable for trail participation by the principal investigator.
Target Size - 66
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2025 Year 12 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067058
Disclaimer: Curated by HT Syndication.
