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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004477
Receipt No. R000005352
Scientific Title Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
Date of disclosure of the study information 2010/11/01
Last modified on 2015/06/20

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Basic information
Public title Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
Acronym Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema
Scientific Title Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
Scientific Title:Acronym Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema
Region
Japan

Condition
Condition Systemic/cutaneous lupus erythematosus
Sjogren's syndrome
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hydroxychloroquine is used for patients with systemic/cutaneous lupus erythematosus or Sjogren's syndrome who have annular erythema on the face and/or trunk as a first choice in most countries other than Japan. In this study, we will evaluate the efficacy and safety of hydroxychloroquine for Japanese systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change of size and/or color of erythematous lesion
Patient satisfaction assessed by visual analog scale
Key secondary outcomes Assessment for safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hydroxychloroquine 200 mg will be administrated once daily. If insufficient, dosage can be escalated to 400 mg twice daily, but not exceed 6.5 mg/kg/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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with systemic/cutaneous lupus erythematosus or Sjogren's syndrome who have annular erythema on the face and/or trunk that are resistant to steroid and/or tacrolimus treatment for external use.
2. Patients without retinopathy examined by ophthalmologist.
Key exclusion criteria 1. Patients with current or previous history of retinopathy.
2. Patients unable to take or unsupplied with 4-aminoquinoline.
3. Body weight is less than 30 Kg.
4. History of pregnancy or lactation.
5. Other patients who were judged to be ineligible for the study by an attending physician.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Takehara
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Dermatology
Zip code
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2000
Email takehara@med.kanazawa-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazuhiko Takehara
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Dermatology
Zip code
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2000
Homepage URL
Email takehara@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

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
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 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
2010 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 29 Day
Last modified on
2015 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005352

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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