Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059029) titled 'A study on the safety and user experience of continuous use of warming cosmetic products' on Sept. 12.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the safety and user experience of the test product after application to the body.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Apply the test product (warming cosmetics) to the specified body parts for 4 weeks.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Healthy Japanese adult women.
2) Participants who understand and can comply with the rules and guidelines throughout the study period.
3) Participants who have provided written informed consent of their own free will after fully understanding the study details.
Key exclusion criteria - 1. Participants with pain due to gout or rheumatism.
2. Participants with neuropathic or traumatic shoulder, knee, or elbow pain.
3. Participants who have undergone or are currently in need of surgery on their shoulder, lower back, or knee.
4. Participants who regularly use cosmetics or quasi-drugs for body care.
5. Participants who are continuously using pharmaceuticals or quasi-drugs on the test area.
6. Participants who are currently receiving, or planning to receive, treatment from a medical institution for the treatment or prevention of a disease on the test area during the study period (e.g., drug therapy, exercise therapy, diet therapy, acupuncture, massage, physical therapy, and other treatments).
7. Participants with a history of alcohol or drug dependence.
8. Participants who have previously experienced allergic symptoms, such as itching, from cosmetics.
9. Participants who have previously experienced skin problems from warming/cooling products (cosmetics, quasi-drugs, or pharmaceuticals).
10. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
11. Participants who have participated in another clinical study (e.g., using cosmetics, foods, drugs, quasi-drugs, or medical devices) within the last 4 weeks prior to informed consent, or who plan to participate in another clinical study during the scheduled period of this study.
12. Participants who are judged to be inappropriate for participation in this study by the principal investigator.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 08 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067482
Disclaimer: Curated by HT Syndication.
