Evaluation of the skin penetration of cosmetics containing honeybee products

UMIN ID: UMIN000054124

Registered date:15/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Adult
• Date of first enrollment: 2024/05/20
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Apply 6 mg/cm2 (37.5 mg total) of royal jelly cream to the inner forearm 2.5 cm square for 2 hours.

Outcome(s)

• Primary Outcome: The amount of skin penetration of the RJ components (Tape stripping)
• Secondary Outcome: Water content of stratum corneum Transepidermal water loss pH Sebum Skin texture

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: 1) Subjects using cosmetics containing royal jelly. 2) Subjects diagnosed with atopic dermatitis and skin hypersensitivity. 3) Subjects attending or planning to attend dermatology clinics (for treatment of atopic dermatitis, etc.). 4) Pregnant or lactating women. 5) Subjects undergoing hospitalization and medication for the treatment of disease. 6) Subjects who have factors or symptoms on the skin of the inner forearm which may affect the test results or who have received cosmetic medical treatment. 7) Subjects receiving hormone replacement therapy (estrogen, progesterone preparations (oral, paste, ointment, etc.)). 8) Subjects who cannot avoid sunburn during the test period. 9) Subjects who work or exercise outdoors for long time. 10) Subjects who cannot be prohibited from receiving beauty care (facial esthetics, epilation, etc.). 11) Subjects participating in another clinical trial. 12) Subjects who have seasonal allergic symptoms such as hay fever and are taking medication during the test period. 13) Subjects taking bee products such as royal jelly and propolis. 14) Subjects who are judged as unsuitable for this study by the investigator.

Related Information

• Primary Sponsor: Yamada Bee Company, Inc.
• Secondary Sponsor: Research Center for Immunological Analysis, Inc.
• Source(s) of Monetary Support: Yamada Bee Company, Inc.