A Validity Study on the Effectiveness of New Combination of Active Ingredients -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-

UMIN ID: UMIN000054258

Registered date:26/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/04/26
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Test Sample
Positive Control 1
Positive Control 2
Negative Control
No Treatment

Outcome(s)

• Primary Outcome: Water Content of the Stratum Corneum Transepidermal Water Loss

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who have any factors (such as inflammation etc.) on the inner side of their forearms that may affect this study. (2) Subjects whose inner forearm is narrow and cannot take the area for measurement. (3) Subjects who are suffering from or undergoing treatment for a serious disease. (4) Subjects diagnosed with a chronic disease and taking any medications that may affect this study. (5) Subjects who are with skin symptoms that may affect this study, and currently under a dermatologist's care for this reason. (6) Subjects who are allergic to test cosmetic ingredients of this study. (7) Subjects who regularly use cosmetics etc. on the inner side of their forearms and cannot stop using them during the test period. (8) Subjects who are pregnant or planning to become pregnant or nursing during the study period. (9) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (10) Subjects who are with irregular lifestyle habits such as shift workers or midnight workers. (11) Subjects who exposed to ultraviolet rays beyond the normal range of their daily life, such as during long time outdoor work, exercise, sea bathing, leisure, etc., or intend to do so during the test period. (12) Subjects who have a history of cosmetic surgery or treatment for the measurement area within 6 months. (13) Subjects who have recently participated in, or are currently participating in, or intend to participate in other clinical trials that may affect this study, especially those involving cosmetics and pharmaceuticals, etc. (14) Subjects who are judged as unsuitable for this study by the investigator for other reasons.

Related Information

• Primary Sponsor: TOYO SHINYAKU Co., Ltd.
• Source(s) of Monetary Support: TOYO SHINYAKU Co., Ltd.