UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055983 |
|---|---|
| Receipt number | R000063982 |
| Scientific Title | The study to evaluate the efficacy of hair growth by royal jelly lotion application: randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/04/30 08:42:32 |
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Basic information
Public title
The study to evaluate the efficacy of hair growth by royal jelly lotion application
Acronym
The study to evaluate the efficacy of hair growth by royal jelly lotion application
Scientific Title
The study to evaluate the efficacy of hair growth by royal jelly lotion application: randomized double-blind placebo-controlled trial
Scientific Title:Acronym
The study to evaluate the efficacy of hair growth by royal jelly lotion application: randomized double-blind placebo-controlled trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hair growth by royal jelly lotion application.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total hair count after 12 weeks application
Key secondary outcomes
Hair thickness after 12 weeks application
Hair length after 12 weeks application
Ratio anagen hairs after 12 weeks application
Ratio terminal hairs after 12 weeks application
Hydration level of scalp after 12 weeks application
FPHL-SI after 12 weeks application
Hair diagnosis after 12 weeks application
Hair gloss after 12 weeks application
Subjective evaluation after 12 weeks application
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics to the scalp during 12 weeks.
Interventions/Control_2
Apply placebo cosmetics to the scalp during 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have indicated their intention to participate in the study, understand the explanations given, and have obtained informed consent.
2) Healthy Japanese males and females between the ages of 30 and 69 who have not violated the exclusion criteria.
3) Subjects with feelings of thinning hair and hair loss.
4) Subjects who can fill out consent forms, questionnaires, and use a diary.
Key exclusion criteria
1) Patients with pathological hair loss such as alopecia areata and androgenetic alopecia.
2) Have a scalp disorder other than alopecia (eczema, psoriasis, tinea capitis, or other scalp infections).
3) Persons with underactive or abnormal thyroid function.
4) Persons with atopic dermatitis.
5) Persons with sun sensitivity.
6) Have ever experienced hypersensitivity to hair restorers, shampoos, or other external medicines.
7) Persons 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) Persons undergoing hair transplantation or hair extension treatment.
12) Those who have used medicinal hair-growth agents (finasteride, minoxidil, carpronium chloride, etc.) or quasi-drugs for hair growth within the past 6 months.
13) Persons who habitually apply or ingest other topical or oral medications, or dietary supplements that may affect the scalp or hair.
14) Persons with a remarkably high percentage of gray hair on the head.
15) Persons who wear hats, helmets, wigs, etc. during the examination period.
16) Persons who consume excessive amounts of alcohol.
17) Persons with a history of serious hepatic, renal, cardiac disease, circulatory system disease, or psychiatric disease.
18) Have a family who works for a pharmaceutical or cosmetics company.
19) Persons 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 subjects deemed ineligible for this study by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
1-11-2, Ebisu, Shibuya-Ku, Tokyo
TEL
03-5793-8712
sakurai@inforward.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
1-11-2, Ebisu, Shibuya-Ku, Tokyo
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi, Hachioji-shi, Tokyo
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社インフォワード/Inforward, inc
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063982
