Whitening evaluation study of a test product

UMIN ID: UMIN000045878

Registered date:28/10/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2021/10/28
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Applying a test product on the face twice a day for 6 weeks.

Outcome(s)

• Primary Outcome: Evaluation of the number of pigmented spots, the skin brightness or melanin amount after continuous use of a test product for 3, 6 weeks.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: 1. Persons who have scratches or eczema on their face. 2. Persons who have experienced medical cosmetic treatment or are planning during the test period. 3. Persons who have experienced special skincare treatments (beauty salons, esthetic treatments, etc.) within the past 4 weeks or are planning during the test period. 4. Persons who use cosmetics containing whitening ingredients or take medicine or supplements claiming whitening function. 5. Persons who have changed or newly started using supplements, facial cosmetics or sunscreens within the past 4 weeks. 6. Those who have been exposed to UV radiation beyond their daily lives within the last 4 weeks or will be exposed during the test period. 7. Persons who work night shifts or day and night shifts. 8. Persons who are being treated at a medical institution for the treatment or prevention of illness, or those who are judged to be in need of treatment. 9. Persons who have a critical illness related to glucose metabolism, lipid metabolism, liver function, renal function, cardiovascular system, respiratory tract, endocrine system, immune system or nervous system, or have an anamnestic history of psychiatric disorder. 10. Persons with a history of alcohol and drug addiction 11. Persons who may develop allergies to cosmetics and foods 12. Persons who are pregnant, lactating, or wish to become pregnant during the study period 13. Persons who have participated in other human studies within the last 4 weeks, or who are planning to participate in other human studies during the study period. 14. Persons who are overly tanned. 15. Persons who are currently using cream-type skincare products. 16. Persons who work for a cosmetics company or have a family member living with them who works for a cosmetics company. 17. Persons who are judged as unsuitable for the study by the investigator (or the person responsible for this study).

Related Information

• Primary Sponsor: KOBAYASHI Pharmaceutical Co., Ltd.
• Source(s) of Monetary Support: KOBAYASHI Pharmaceutical Co., Ltd.