Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062048) titled 'Study of hair growth efficacy applying hair tonic' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Verify the hair growth efficacy of hair tonic B
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Apply hair tonic A twice a day for 24 weeks
Interventions/Control_2 - Apply hair tonic B twice a day for 24 weeks
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Female
Key inclusion criteria - 1) Participants who have indicated their intention to participate in the study, understand the explanations given, and have obtained informed consent.
2) Healthy Japanese females between the ages of 30 and 69 who have not violated the exclusion criteria.
3) Participants with feelings of thinning hair and hair loss.
4) Participants who can fill out consent forms, questionnaires, and use a diary.
Key exclusion criteria - 1) Participants with pathological hair loss such as alopecia areata.
2) Have a scalp disorder other than alopecia (eczema, psoriasis, tinea capitis, or other scalp infections).
3) Participants with underactive or abnormal thyroid function.
4) Participants with atopic dermatitis.
5) Participants with sun sensitivity.
6) Participants who have ever experienced hypersensitivity to hair restorers, shampoos, or other external medicines.
7) Participants who have experienced hypersensitivity to rubbing alcohol, hair growth products, or other cosmetics containing alcohol.
8) Pregnant, lactating, or intending to become pregnant.
9) Received hormone replacement therapy within the past year or are taking oral contraceptives.
10) Received radiation therapy to the head or cancer chemotherapy treatment within the past 6 months.
11) Participants undergoing hair transplantation or hair extension treatment.
12) Participants who have used medicinal hair-growth agents (minoxidil, carpronium chloride, etc.) or quasi-drugs for hair growth within the past 6 months.
13) Participants who habitually apply or ingest other topical or oral medications, or dietary supplements that may affect the scalp or hair.
14) Participants with a remarkably high percentage of gray hair on the head.
15) Participants who wear hats, helmets, wigs, etc., during the examination period.
16) Participants who consume excessive amounts of alcohol.
17) Participants with a history of serious hepatic, renal, cardiac disease, circulatory system disease, or psychiatric disease.
18) Participants who have a family member who works for a pharmaceutical or cosmetics company.
19) Participants who are currently participating or have participated within the past 3 months in clinical trials, usage surveys, or product monitoring related to cosmetics and pharmaceuticals.
20) Other Participants deemed ineligible for this study by the principal investigator.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 03 Day
Date of IRB - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 07 Month 08 Day
Last follow-up date - 2027 Year 01 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070992
Disclaimer: Curated by HT Syndication.