Tokyo, Oct. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059517) titled 'An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older' on Oct. 27.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Infoward Co., Ltd.
Condition:
Condition - Xerosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the efficacy of this drug based on the assessment of safety and degree of improvement.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Apply this drug to the lower legs twice daily (morning and evening) for 4 weeks.
Eligibility:
Age-lower limit - 75
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Individuals who express willingness to participate in the study, understand the explanation, and can provide written informed consent.
2. Japanese men and women aged 75 years or older.
3. Individuals who are aware of dryness of the skin on the lower legs.
4. Individuals who can visit Infoward Co., Ltd. Ebisu Skin Research Center (Shibuya-ku, Tokyo) without the need for special assistance or support.
5. Individuals who do not require special assistance or support for understanding informed consent, giving consent, and withdrawing consent (i.e., those who do not need a legal representative).
6. Individuals who are able to fill out documents such as consent forms, questionnaires, and usage diaries.
Key exclusion criteria - 1. Individuals diagnosed with type 1 or type 2 diabetes.
2. Individuals diagnosed with malignant tumors.
3. Individuals diagnosed with skin diseases (such as atopic dermatitis, acne vulgaris, psoriasis, etc.).
4. Patients undergoing artificial dialysis.
5. Individuals diagnosed with liver diseases.
6. Individuals infected with infectious diseases (HBV/HCV/HIV/syphilis).
7. Individuals currently taking steroid preparations or immunosuppressants.
8. Individuals who have regularly used pharmaceuticals, quasi-drugs, cosmetics, etc. for moisturizing purposes on the lower legs within 4 weeks prior to the start of the study (temporary use is permitted).
9. Individuals who consume alcohol excessively.
10. Individuals currently participating or who have participated within the past 3 months in clinical trials, usage surveys, or product monitoring related to investigational drugs, cosmetics, pharmaceuticals, etc.
11. Individuals who have experienced severe allergic reactions in the past due to the use of topical medications, cosmetics, quasi-drugs, or other products.
12. Individuals employed by pharmaceutical manufacturers or cosmetics companies, including the subjects themselves or their family members.
13. Any other individuals deemed unsuitable by the study physician.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 09 Day
Anticipated trial start date - 2025 Year 11 Month 25 Day
Last follow-up date - 2025 Year 12 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068080
Disclaimer: Curated by HT Syndication.
