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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: 2 April 2019
Main ID:  JPRN-UMIN000004477
Date of registration: 01/11/2010
Prospective Registration: Yes
Primary sponsor: Kanazawa University Graduate School of Medical Science
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
Scientific title:
Date of first enrolment: 2010/11/01
Target sample size: 10
Recruitment status: Complete: follow-up complete
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not applicable
Countries of recruitment
Name: Kazuhiko Takehara   
Address:  13-1 Takaramachi, Kanazawa Japan
Telephone: 076-265-2000
Affiliation:  Kanazawa University Graduate School of Medical Science Department of Dermatology
Key inclusion & exclusion criteria
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.

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.

Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Systemic/cutaneous lupus erythematosus Sjogren's syndrome
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.
Primary Outcome(s)
Change of size and/or color of erythematous lesion
Patient satisfaction assessed by visual analog scale
Secondary Outcome(s)
Assessment for safety
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Approval date:
Results available:
Date Posted:
Date Completed:
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