|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000017617 |
|
Date of registration:
|
19/05/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosis
|
|
Scientific title:
|
Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosis - BTX-A on Raynaud's phenomenon in SSc |
|
Date of first enrolment:
|
2014/11/01 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020417 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Sei-ichiro Motegi |
|
Address:
|
3-39-22 Showa, Maebashi, Gunma 371-8511.
Japan |
|
Telephone:
|
027-220-8284 |
|
Email:
|
smotegi@gunma-u.ac.jp |
|
Affiliation:
|
Gunma University Graduate School of Medicine Department of Dermatology |
|
|
Name:
|
Sei-ichiro Motegi |
|
Address:
|
3-39-22 Showa, Maebashi, Gunma 371-8511.
Japan |
|
Telephone:
|
027-220-8284 |
|
Email:
|
smotegi@gunma-u.ac.jp |
|
Affiliation:
|
Gunma University Graduate School of Medicine Department of Dermatology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Patients under the age 18, with the pregnancy or having the past medical histories with BTX-A were excluded.
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Raynaud's phenomenon
|
|
Intervention(s)
|
|
Botulinum toxin A injection
|
|
Primary Outcome(s)
|
|
The change in severity of RP, including the frequency, pain, color and duration, by the Raynaud score and VAS at 4 weeks after treatment compared with the baseline.
|
|
Source(s) of Monetary Support
|
|
Japanese Ministry of Health, Labour and Welfare
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/08/2015 |
|
URL:
|
|
|
|