UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059155 |
|---|---|
| Receipt number | R000067665 |
| Scientific Title | Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/09/22 11:31:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent
Acronym
Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent
Scientific Title
Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent
Scientific Title:Acronym
Clinical Study to Evaluate the Hair Growth Effects of a Hair Growth Agent
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of the hair growth agent for women with thinning hair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of scalp condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using test article for 16 consecutive weeks
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Japanese female subjects aged 40 years or older and younger than 60 years at the time of consent.
2.Subjects who have recently become concerned about hair thinning and/or hair loss.
3.Subjects who perceive a decrease in hair volume and/or experience discomfort in hair manageability (e.g., when running fingers through the hair).
4.Subjects classified as Ludwig classification type I-2 through type II-1.
5.Subjects who have received a sufficient explanation regarding the purpose and details of this study, are capable of providing informed consent, fully understand the information provided, and voluntarily agree in writing to participate in this study.
Key exclusion criteria
1.Subjects who have undergone hair transplantation or who are wearing wigs or hairpieces on the scalp evaluation area.
2.Subjects who present with inflammation or dermatological disease on the scalp evaluation area.
3.Subjects who have factors at the scalp evaluation area that may affect the study results (e.g., urticaria, inflammatory conditions, eczema, trauma, acne, pimples, warts, pigmentation, or residual traces of these conditions).
4.Subjects with a past or current history of atopic dermatitis, or those with an atopic diathesis.
5.Subjects who have previously received aesthetic medical procedures at the scalp evaluation area (e.g., botulinum toxin injections, hyaluronic acid or collagen fillers, photofacial therapy), or who plan to undergo such procedures during the study period.
6.Subjects who have received, within the past 4 weeks, or plan to receive during the study period, special skincare treatments to the scalp evaluation area (e.g., beauty salon treatments, esthetic procedures, head spa).
7.Subjects who are continuously using skincare products, cosmetics, quasi-drugs, health foods, topical preparations (pharmaceuticals or quasi-drugs), or oral medications that claim efficacy similar to or related to the efficacy being investigated in this study (e.g., hair growth effects).
8.Subjects who have used, within the past 4 weeks, health foods or supplements (e.g., products containing saw palmetto or zinc), or hair care products (e.g., shampoos, conditioners, treatments, hair essences, or hair growth agents) that claim hair growth, hair restoration, or anti-hair loss effects (for hair growth agents, within the past 6 months).
9.Subjects who are using cosmetics applied to the scalp evaluation area (e.g., hair tonics).
And others (omitted due to overcapacity).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Sato |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
External Medicine & Hair Care Product Development Division
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-8213
haircareG@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Sato |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
External Medicine & Hair Care Product Development Division
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-8213
Homepage URL
haircareG@rohto.co.jp
Sponsor or person
Institute
ROHTO PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, Tokyo
Tel
03-6273-2214
ethics_board@drc-web.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067665
