UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023887 |
|---|---|
| Receipt number | R000027511 |
| Scientific Title | Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment: Case report |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/09/01 13:43:57 |
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Basic information
Public title
Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment: Case report
Acronym
Botulinum toxin in Behcet's disease
Scientific Title
Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment: Case report
Scientific Title:Acronym
Botulinum toxin in Behcet's disease
Region
| Japan |
Condition
Condition
Behcet's disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To report a unique case in which subcutaneous injections of botulinum toxin to treat axillary hyperhidrosis appeared to trigger acute uveitis in a patient with Behcet's disease even though his condition had been stable while he received periodic infliximab treatment. The patient received his regularly scheduled infliximab injection, and the uveitis resolved quickly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An ultra-widefield high-resolution digital image of fundus, anterior chamber flare, best corrected visual acuity, and intraocular pressure were measured before and after the Botulinum toxin-induced acute uveitis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
A patient with Behcet's disease in which injections of botulinum toxin appeared to trigger uveitis even though his condition had been stable while he received periodic infliximab treatment.
Key exclusion criteria
None.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Zako |
Organization
Asai hospital
Division name
Department of Ophthalmology
Zip code
Address
178-1 Yakata-cho, Seto, Aichi
TEL
0561843111
mzako@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Zako |
Organization
Asai hospital
Division name
Department of Ophthalmology
Zip code
Address
178-1 Yakata-cho, Seto, Aichi
TEL
0561843111
Homepage URL
mzako@aol.com
Sponsor or person
Institute
Department of Ophthalmology
Asai hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人宏和会あさい病院（愛知県）/Asai Hospital (Aichi Prefecture)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 04 | Day |
Other
Other related information
To examine Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2016 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027511
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
