UMIN-CTR Clinical Trial

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 Motegi Middle name Last name Sei-ichiro
Organization	Gunma University Graduate School of Medicine
Division name	Department of Dermatology
Zip code	371-8511
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 Sei-ichiro Middle name Last name Motegi
Organization	Gunma University Graduate School of Medicine
Division name	Department of Dermatology
Zip code	371-8511
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	Gunma University
Address	Gunma
Tel	027-220-7111
Email	gunmaciru-office@umin.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	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	10
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	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 12 Month 12 Day
Last follow-up date	2019 Year 05 Month 14 Day
Date of closure to data entry	2019 Year 05 Month 14 Day
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	2020 Year 05 Month 10 Day

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