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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024818
Receipt No. R000028566
Scientific Title The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis
Date of disclosure of the study information 2016/11/14
Last modified on 2018/05/23

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Basic information
Public title The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis
Acronym The efficacy and safety of BTX-B on digital ulcers in patients with SSc
Scientific Title The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis
Scientific Title:Acronym The efficacy and safety of BTX-B on digital ulcers in patients with SSc
Region
Japan

Condition
Condition digital ulcers in systemic sclerosis patients
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of BTX-B on digital ulcers in Japanese patients with SSc.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of the patients which digital ulcer was healed by BTX-B at 8 weeks after treatment compared with that treated with placebo control.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 placebo subcutaneously injection into hands with digital ulcers
Interventions/Control_2 botulinum toxin type B subcutaneously injection into hands with digital ulcers
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

Not applicable
Gender Male and Female
Key inclusion criteria All patients fulfilled the criteria of SSc proposed by the American College of Rheumatology and the American College of Rheumatology/European League Against Rheumatism classification criteria.

SSc patients with digital ulcers
Key exclusion criteria Patients under the age 18, with the pregnancy or having the past medical histories with BTX were excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sei-ichiro Motegi
Organization Gunma University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511.
TEL 027-220-8284
Email smotegi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sei-ichiro Motegi
Organization Gunma University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address 3-39-22 Showa, Maebashi, Gunma 371-8511.
TEL 027-220-8284
Homepage URL
Email gunmaciru-office@umin.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour
and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 29 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 14 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028566

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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