UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061569 |
|---|---|
| Receipt number | R000070379 |
| Scientific Title | A Single-Center Clinical Study Evaluating the Efficacy and Safety of Needle Radiofrequency Treatment in Patients with Male Androgenetic Alopecia and Female Pattern Hair Loss |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/18 10:20:45 |
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Basic information
Public title
A Single-Center Prospective Interventional Study Evaluating the Efficacy and Safety of Needle Radiofrequency-Based Regenerative Therapy for Male and Female Pattern Hair Loss
Acronym
A Study Evaluating the Effectiveness and Safety of Needle Radiofrequency Treatment for Male and Female Pattern Hair Loss
Scientific Title
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Needle Radiofrequency Treatment in Patients with Male Androgenetic Alopecia and Female Pattern Hair Loss
Scientific Title:Acronym
NRF-MAGA/FPHL Study
Region
| Japan |
Condition
Condition
Male Androgenetic Alopecia and Female Pattern Hair Loss
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of needle RF for MAGA and FPHL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hair shaft diameter parameters (Maximum hair Diameter and Terminal Hair %) before and 12 months after starting treatment
Key secondary outcomes
Changes in Quantitative Trichoscopic Evaluation System: QTES scores
Changes in hair density and hair number per follicular unit (HN/FU)
Clinical photographic assessment
Frequency and severity of adverse events
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
| Device,equipment |
Interventions/Control_1
Needle radiofrequency treatment using an non-insulated microneedle bipolar radiofrequency device will be applied to areas affected by hair loss on the scalp. Treatments will be performed five times at intervals of approximately 1.5 to 2 months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults diagnosed with androgenetic alopecia or female pattern hair loss
Including patients with poor response to previous hair restoration treatments, defined as a decrease in QTES score after prior therapy
Ability to provide written informed consent
Key exclusion criteria
Patients diagnosed with alopecia other than MAGA/FPHL.
Patients with alopecia associated with collagen diseases, thyroid disorders, infections, or malignancies.
Patients with scalp disorders affecting evaluation, including seborrheic dermatitis, tinea capitis, or atopic dermatitis.
Any condition deemed inappropriate by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamishima |
Organization
Tokyo Midtown Skin/Aesthetic Clinic Noage
Division name
Department of Dermatology
Zip code
107-6206
Address
Midtown Tower 6F 9-7-1 Akasaka Minato-ku Tokyo Japan
TEL
0354130082
t-kamishima@tokyomidtown-mc.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Ito |
Organization
Advanced Medical Care Inc.
Division name
Noage Dental Division
Zip code
107-6206
Address
Midtown Tower 6F 9-7-1 Akasaka Minatoku Tokyo Japan
TEL
0354130082
Homepage URL
a-ito@amcare.co.jp
Sponsor or person
Institute
Tokyo Midtown Clinic
Institute
Department
Personal name
Funding Source
Organization
Tokyo Midtown Skin/Aesthetic Clinic Noage
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Midtown Medical Center Ethical Review Board
Address
Midtown Tower 6F 9-7-1 Akasaka Minatoku Tokyo Japan
Tel
0354130082
k-aramaki@amcare.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
東京ミッドタウン皮膚科形成外科クリニック・ノアージュ
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study using records of treatments and follow-up performed as part of routine clinical practice, and no additional examinations or treatments were conducted for research purposes.
This study is an exploratory observational study and is not intended to verify treatment efficacy, rather, it aims to obtain preliminary data that may serve as a basis for future research.
Because this study uses routinely collected clinical information, informed consent is obtained using an opt-out approach. Information about the study is disclosed through in-hospital notices and the medical institutions website, and study subjects may refuse participation at any time.
The collected data are managed in a manner that prevents personal identification, and only anonymized data are used for analysis. All research data are strictly stored under the responsibility of the principal investigator and are not used for purposes other than this study.
The principal investigator and all study collaborators have no conflicts of interest to disclose in relation to this study.
The results of this study may be published in academic journals or presented at scientific meetings.
Even if a study subject chooses to refuse participation in the study, no disadvantages in medical care will result.
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070379
