Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058172) titled 'Verification of the effect of the use of the test product on stress -Randomized crossover controlled trial-' on March 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - KOBAYASHI Pharmaceutical Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The study will examine the effect of the test product on stress when used by women who suffer from acne.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Have participants smell the test product for 1 minute
Interventions/Control_2 - Apply the test product to their face with their hands for 1 minute
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Healthy female university students aged 18 or older who suffer from acne
2) Non-smokers
3) Not receiving medical treatment for hypertension, diabetes, mental illness, sleep disorders, or serious illnesses
4) Participants who have received an explanation of the study, fully understood the contents, and provided their own informed consent
Key exclusion criteria - 1) Heavy alcohol drinkers (average alcohol intake of 60g or more per day)
2) Individuals who have undergone hormone replacement therapy or are taking oral contraceptives within the past year
3) Individuals who are using drugs that affect the secretion of cortisol (steroids, phenytoin, phenobarbital)
4) Individuals with extremely irregular eating habits, or those with irregular lifestyles such as shift workers or night shift workers
5) Individuals taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that take into consideration their effects on the autonomic nervous system and sleep
6) Individuals with blocked noses due to hay fever or other conditions that make it difficult to distinguish between different scents
7) Individuals who are allergic to the test products
8) Individuals who prefer fragrance-free products, or those who dislike the scent of the test product.
9) Individuals who are pregnant, wish to become pregnant, or are breastfeeding.
10) Individuals with irregular menstrual cycles (average menstrual cycle of 24 days or less, or 39 days or more).
11) Individuals who are regularly visiting a clinic for acne treatment.
12) Individuals with atopic skin.
13) Individuals who have previously experienced abnormal skin reactions such as redness, swelling, itching, irritation, discoloration (e.g., vitiligo), or hyperpigmentation after using cosmetic products containing ethanol, isopropylmethylphenol, or dipotassium glycyrrhizate.
Target Size - 7
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 06 Month 12 Day
Date of IRB - 2026 Year 06 Month 12 Day
Anticipated trial start date - 2025 Year 06 Month 13 Day
Last follow-up date - 2025 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066502
Disclaimer: Curated by HT Syndication.
