Tokyo, Dec. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060207) titled 'Clinical study of the combined effect of laser treatment and NMN intake on removing aging spots' on Dec. 25.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Mitsubishi Corporation Life Sciences Limited
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluating the effectiveness of NMN supplementation on laser treatment for aging spots.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Phase1(Control Food),Washout,Phase2(Test Food)
Interventions/Control_2 - Phase1(Test Food),Washout,Phase2(Control Food)
Eligibility:
Age-lower limit - 35
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Individuals who have received a full explanation of the purpose and content of this study,are competent to consent,fully understand the content,voluntarily volunteer to participate,and can provide written consent to participate in this study.
2.Men and women aged 35 years or older at the time of consent.
3.Individuals deemed appropriate for participation in this study by the principal investigator.
4.From among those who meet the above criteria,priority will be given to individuals concerned about skin aging spots (those deemed appropriate for this study by the principal investigator after reviewing images of the applicant's aging spots).
Key exclusion criteria - 1.Subjects with a current or past serious illnesses,including brain disease,malignant tumors,immune disorders,diabetes,liver disease (hepatitis),liver damage,kidney disease,heart disease,thyroid disease,adrenal gland disease,or other metabolic disorders.
2.Subjects currently undergoing treatment for psychiatric disorders,including sleep disorders (insomnia) and depression.
3.Subjects who may have allergic reactions to the test food (vitamins),supplements,and ingredients in the test food and placebo foods,as well as to other foods and medications.
4.Subjects who are not using topical preparations or foods (including those containing NMN or N-methyl-N ... Individuals who are unable to refrain from using or consuming any of the following substances from two weeks prior to or during the study: D+ precursors,niacin (vitamin B3,nicotinamide,nicotinamide), glutathione,cysteine,yeast extract,vitamin C,vitamin E,vitamin A (retinol),tretinoin,placenta,hyaluronic acid,collagen,astaxanthin,xanthophyll,lycopene,beta-carotene,procyanidins,collagen peptides,heparinoids,etc.
5.Individuals currently participating in other clinical trials,those who have participated in other clinical trials within the past three months,or those who may undergo any of the above-mentioned tests or procedures during this study period.
6.Individuals who have difficulty completing various questionnaires.
7.Individuals who are pregnant,planning to become pregnant,or breastfeeding.
8.Subjects who have experienced severe sunburn within the past month.
9.Subjects with keloid tendencies,photosensitivity,or taking photosensitizing medications (e.g., tetracycline).
10.Subjects who have received treatment for skin aging spots (including laser treatment) within the past three months.
11.Subjects receiving immunosuppressive therapy.
12.Subjects who are otherwise deemed unsuitable by the investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 15 Day
Date of IRB - 2025 Year 12 Month 18 Day
Anticipated trial start date - 2026 Year 01 Month 08 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068824
Disclaimer: Curated by HT Syndication.