Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056762) titled 'Evaluation of the Effect of Test Food on skin conditions' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - N/A
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to examine effects of a test food on skin conditions.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of a test food for 8 weeks
Interventions/Control_2 - Oral ingestion of a placebo food for 8 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Female
Key inclusion criteria - 1)Japanese females aged 30-59 years when informed consent.
2)Individuals who are healthy without chronic physical illness, including skin diseases.
3)Individuals who can detect ultraviolet erythema on the skin of the back.
4)Individuals who are type II or III of Fitzpatric skin type.
5)Individuals whose written informed consent has been obtained.
6)Individulals who can visit an inspection facility and be inspected in designated days.
7)Individuals judged appropriate for the study by the principal.
Key exclusion criteria - Individuals
1)using medical products.
2)who have or are being treated for skin disease symptoms.
3)with wounds or inflammation at the skin measurement points.
4)with a history of serious liver, kidney, heart, lung, or blood disease.
5)with a history of serious gastrointestinal disease.
6)with alcoholism or a mental illness.
7)who used or applied medications for disease treatment in the past 1 month.
8)who have an severe reaction to sunlight.
9)who have irregular menstrual cycles.
10)with food allergies.
11)with allergies or hypersensitivity to drugs or cosmetics.
12)with serious anemia.
13)who smoke.
14)who are or may be pregnant, or lactating.
15)whose lifestyle will change during the trial.
16)who are exposed to exceeded UV-light than in daily life.
17)who had a habit of ingesting foods for specified health uses or supplements containing ingredients of the test food in the past 3 months or will ingest them during the trial.
18)who had a habit of ingesting foods for specified health uses or supplements that improve skin condition in the past 3 months or will ingest them during the trial.
19)who had a habit of ingesting or applying anti-inflammatory drugs or drugs purporting to improve skin in the past 3 months.
20)who conducted hormone replacement therapy in the past 6 months.
21)who currently have undergone aesthetic salon, cosmetic treatment or cosmetic therapy under the supervision of a physician currently or within the past 6 months.
22)who plan to remove hair from the evaluation site during the trial.
23)who were hospitalized and received treatment in the past 6 months.
24)who participated in other clinical studies within one month of consent for this study or plan to participate in other clinical studies.
25)who judged inappropriate for this study by the principal investigator.
Target Size - 66
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 12 Month 23 Day
Date of IRB - 2024 Year 12 Month 23 Day
Anticipated trial start date - 2025 Year 01 Month 21 Day
Last follow-up date - 2025 Year 04 Month 18 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064863
Disclaimer: Curated by HT Syndication.
