Clinical study of whitening cream

UMIN ID: UMIN000048987

Registered date:01/10/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pigmentation
• Date of first enrollment: 2022/10/01
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Apply the test product to the entire face twice a day (morning and night) for 12 months.

Outcome(s)

• Primary Outcome: Visual evaluation
• Secondary Outcome: Blood tests (T3, T4, TSH levels)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 49years-old
• Gender: Female
• Exclude criteria: 1. Persons with a smoking habit. 2. Persons with a history of serious illness within the past 5 years.(pigmentation and thyroid function) 3. Persons who currently have thyroid dysfunction. 4. Persons who have received treatment such as immunosuppression within the past 3 months. 5. Persons who may have allergic reactions to cosmetic ingredients. 6. Persons with chronic skin diseases such as atopic dermatitis. 7. Persons at risk of showing hay fever symptoms during the study period. 8. Persons with scars, warts, pimples, permanent makeup, burns, etc. on the face that would affect the evaluation measurement. 9. Persons receiving hormone replacement therapy. 10. Persons who have experience in cosmetic medicine on the face. 11. Persons who have difficulty maintaining lifestyle habits.(eating, exercising, sleeping, skin care, etc.) 12. Persons who are pregnant, lactating, may be pregnant, or wish to become pregnant. 13. Persons who are participating in other clinical study at the start of this study. 14. Individuals or family members who work for a company that develops, manufactures, or sells cosmetics.

Related Information

• Primary Sponsor: Sansho Pharmaceutical Co.,Ltd.
• Secondary Sponsor: Tokyo Saiseikai Central Hospital
• Source(s) of Monetary Support: None