Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059455) titled 'A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans' on March 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
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 - To investigate the effects of continuous use of test products with different fragrances and application methods on psychological stress and skin condition in women concerned about acne.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The investigational product is applied using a cotton wipe.
Interventions/Control_2 - The investigational product is applied by patting with the hands.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key 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.
Key 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.
Target Size - 36
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 09 Month 03 Day
Date of IRB - 2025 Year 09 Month 03 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2026 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067988
Disclaimer: Curated by HT Syndication.
