UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050573 |
|---|---|
| Receipt number | R000057564 |
| Scientific Title | Investigation of the usefulness of FD-PRP in patients with alopecia areata |
| Date of disclosure of the study information | 2023/03/13 |
| Last modified on | 2025/03/14 09:03:02 |
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Basic information
Public title
Investigation of the usefulness of FD-PRP in patients with alopecia areata
Acronym
Investigation of the usefulness of FD-PRP in patients with alopecia areata
Scientific Title
Investigation of the usefulness of FD-PRP in patients with alopecia areata
Scientific Title:Acronym
Investigation of the usefulness of FD-PRP in patients with alopecia areata
Region
| Japan |
Condition
Condition
AGA,FAGA
Classification by specialty
| Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the condition of hair on the top of the head and at the hairline before and after treatment and to evaluate the usefulness of FD-PRP for patients with alopecia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appearance of the parietal area and hairline before and 6 months after treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women between the ages of 18 and 60 at the time of consent.
2. Patients who wish to undergo PRP therapy of their own volition.
3. Patients who meet the following criteria according to hair loss classification
Men with thinning hair Hamilton-Norwood Scale I-IV
Female with thinning hair Ludwig Scale I-1 to II-2
4. Patients who have given written consent to participate in this study
Key exclusion criteria
1. Patients with non-patterned alopecia and scarring alopecia
2. Patients with a history of hypersensitivity to concomitant medications
3. Patients with a history of bleeding disorders
4. Patients taking anticoagulants (aspirin, warfarin, heparin)
5. Patients with active local infection
6. Patients with keloid tendency on the scalp
7. Patients with a history of psoriasis, lichen planus, or vitiligo
8. Patients who are participating in other clinical trials or who have been participating in such trials for less than 6 months.
9. Other patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Sato |
Organization
Medical Corporation TMC. Tokyo Memorial Clinic
Division name
Formation Surgery
Zip code
151-0053
Address
2-16-7 Yoyogi, Shibuya-ku, Tokyo
TEL
03-5351-0309
drsato@crux.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiromu |
| Middle name | |
| Last name | Katsuta |
Organization
Re-Life.inc
Division name
Clinical Development Division
Zip code
170-0013
Address
5F Koushin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5928-2501
Homepage URL
hkatsuta@relife-inc.com
Sponsor or person
Institute
Medical Corporation TMC. Tokyo Memorial Clinic
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation TMC. Tokyo Memorial Clinic
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
Ethics Review Committee, Abe Clinic, San-yukai Medical Corporation
Address
Nippori Ekimae Chuo Building 5F, 6-60-10 Higashinippori, Arakawa-ku, Tokyo
Tel
03-5810-7808
abecl-rinri@medicos-group.com
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
| 2023 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items
1) Background of study subjects
Age, gender, height, weight, history of alopecia treatment, medical history
2)Physician findings
Photographs of the parietal area and hairline
3)Subjective findings
Survey of improvement in alopecia status at 6 months post-treatment
4) Concomitant medication survey
Record any changes in the dosage and administration of regular medications or the addition of new medications during the study period.
Management information
Registered date
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057564
