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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011622
Receipt No. R000013575
Scientific Title Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Date of disclosure of the study information 2013/10/01
Last modified on 2019/03/08

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Basic information
Public title Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Acronym Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Scientific Title Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Scientific Title:Acronym Evaluation of effectiveness of smashed skin grafting therapy for vitiligo vulgaris
Region
Japan

Condition
Condition vitiligo vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To calculate depigmented ratio and evaluate effectiveness of the treatment after smash grafting therapy for vitiligo vulgaris
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the effectiveness by calculating depigmented ratio at 3 and 6 months after treatment
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 Obtain shaved skin from donor sites, cut into small pieces by scissors and apply to the dermabraded recipient sites.
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 1. Vitiligo vulgaris patient whose lesion has not changed for at least a year.
2. Disease type: diffuse, localized, segmented.
3. Patient with written informed consent for the treatment.
Key exclusion criteria 1. Vitiligo vulgaris patient whose lesion is progressing.
2. Patient with severe systemic disease.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Setsuya Aiba
Organization Graduate School of Medicine, Tohoku University
Division name Department of Dermatology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL 022-717-7271
Email saiba@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Kimura
Organization Graduate School of Medicine, Tohoku University
Division name Department of Dermatology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL 022-717-7271
Homepage URL
Email yutakakimura@m.tohoku.ac.jp

Sponsor
Institute Department of Dermatology
Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 02 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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