UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027915 |
|---|---|
| Receipt number | R000031977 |
| Scientific Title | Efficacy of cultured epidermal autograft in vitiligo, refractory scar and refractry skin culcer. |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2023/10/09 13:31:15 |
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Basic information
Public title
Efficacy of cultured epidermal autograft in vitiligo, refractory scar and refractry skin culcer.
Acronym
Efficacy of cultured epidermal autograft in vitiligo and so on.
Scientific Title
Efficacy of cultured epidermal autograft in vitiligo, refractory scar and refractry skin culcer.
Scientific Title:Acronym
Efficacy of cultured epidermal autograft in vitiligo and so on.
Region
| Japan |
Condition
Condition
vitiligo, refractory scar, refractory skin ulcer
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cultured epidermal autograft in the vitiligo, refractory scar and refractory skin ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Take rate of cultured epdermal sheets at one week after autograft
Improvement rate of color tone, skin viscoelasticity and ulcer area
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
| Maneuver |
Interventions/Control_1
the epidermis of the lesion is erased and treated by cultured epidermal autograft
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who has vitiligo, refractory scar and refractory skin ulcer.
The person who understand this trial.
The person who does not meet the below standard
Key exclusion criteria
Allergy to antibiotic
Allergy to animal
Skin malignant tumor
Mental disorder
Pregnant, lactating woman
Infectious disease
The last person who precipitates this trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Toriyama |
Organization
Nagoya City University
Division name
Plastic and reconstructive surgery
Zip code
467-8602
Address
1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
toriyama@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Toriyama |
Organization
Nagoya City University
Division name
Plastic and reconstructive surgery
Zip code
467-8602
Address
1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
Homepage URL
toriyama@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya city university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gamagori City Hospital, Department of Dermatology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1-Kawasumi, Mizuhocho, Mizuho-ku, Nagoya, Japan
Tel
052-858-7215
clinical_reserch@med.nagoya-cu.ac.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
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031977
