Healthy adults
Conditions
Interventions
The investigational product is applied using a cotton wipe.
The investigational product is applied by patting with the hands.
The control product is applied using a cotton wipe.
Sponsors
KOBAYASHI Pharmaceutical Co., Ltd.
Otemon Gakuin Educational Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Healthy female students aged 18 years or older who are concerned about acne. 2) Non-smokers. 3) Individuals who are not currently undergoing treatment or receiving medical care for hypertension, diabetes, mental illness, sleep disorders, or other serious medical conditions. 4) Individuals who are able to use the investigational product (a wipe-off toner) before their currently used lotion during the study period. 5) Individuals who have provided written informed consent after receiving a full explanation of the study and demonstrating a sufficient understanding of its contents.
Exclusion criteria
Exclusion criteria: 1) Individuals with heavy alcohol consumption (average daily intake of 60g or more). 2) Individuals who have received hormone replacement therapy within the past year or are currently taking oral contraceptives. 3) Individuals using medications that affect cortisol secretion (e.g., steroids, phenytoin, phenobarbital). 4) Individuals with extremely irregular dietary habits or an irregular life rhythm, such as shift workers or night workers. 5) Individuals consuming Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other health foods (including supplements) that may affect the autonomic nervous system or sleep. 6) Individuals unable to distinguish fragrances due to nasal congestion from hay fever or other reasons. 7) Individuals with an allergy to the test product. 8) Individuals who prefer fragrance-free products or dislike the fragrance of the test product. 9) Individuals who are pregnant, planning to become pregnant, or breastfeeding. 10) Individuals with an irregular menstrual cycle (average cycle length of 24 days or less, or 39 days or more). 11) Individuals continuously receiving medical treatment for acne. 12) Individuals receiving aesthetic treatments, chemical peels, or laser therapy at specialized institutions. 13) Individuals with atopic dermatitis. 14) Individuals who have previously experienced skin abnormalities such as redness, swelling, itching, irritation, color loss (e.g., vitiligo), or darkening after using cosmetics containing ethanol, isopropyl methylphenol, or dipotassium glycyrrhizate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in psychological stress indicators during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in heart rate, estimated hemoglobin value, stress hormones, and sex hormones during the study period Changes in skin condition during the study period Changes in the questionnaire on skin condition, skincare habits, sleep, and mood during the study period Questionnaire on the feeling of use of the test product | — |
Countries
Japan
Contacts
Public ContactYukino Koshinaka
KOBAYASHI Pharmaceutical Co., Ltd. Life Science Research Department R&D Headquarters
Outcome results
None listed