UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019216 |
|---|---|
| Receipt number | R000022062 |
| Scientific Title | The evaluation of hydroxychoroquine (HCQ) for cutaneous lupus erythematosus (LE) including LE and Sjogren syndrome |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/02/12 15:09:27 |
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Basic information
Public title
The evaluation of hydroxychoroquine (HCQ) for cutaneous lupus erythematosus (LE) including LE and Sjogren syndrome
Acronym
The evaluation of hydroxychoroquine for cutanous lupus erythematosus
Scientific Title
The evaluation of hydroxychoroquine (HCQ) for cutaneous lupus erythematosus (LE) including LE and Sjogren syndrome
Scientific Title:Acronym
The evaluation of hydroxychoroquine for cutanous lupus erythematosus
Region
| Japan |
Condition
Condition
cutaneous lupus erythmetosus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The assessment of effectiveness and safety of hydroxychoroquine for cutanous lupus erythematosus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The assessment (color, size, induration) of effectiveness of hydroxychoroquine for cutanous lupus erythematosus will be assessed every one month.
Key secondary outcomes
The assessment of safety of hydroxychoroquine for cutanous lupus erythematosus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
application dose of HCQ is 200-400mg/day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patents with cutaneous lupus erythematosus
Key exclusion criteria
patients with the other inflammatory skin diseases
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
185-1, Kohasu, Okohcho, Nankoku, Kochi
TEL
088-880-2363
nakajimk@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Kochi Medical School, Kochi University
Zip code
Address
Department of Dermatology
TEL
088-880-2363
Homepage URL
nakajimk@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Kochi Medical School, Kochi University
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
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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Hydroxychoroquine was effective for three patients with CLE.
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022062
| 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 |
