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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000004477 |
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Date of registration:
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01/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
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Scientific title:
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Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk - Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema |
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Date of first enrolment:
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2010/11/01 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005352 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuhiko Takehara |
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Address:
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13-1 Takaramachi, Kanazawa
Japan |
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Telephone:
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076-265-2000 |
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Email:
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takehara@med.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Graduate School of Medical Science Department of Dermatology |
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Name:
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Kazuhiko Takehara |
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Address:
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13-1 Takaramachi, Kanazawa
Japan |
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Telephone:
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076-265-2000 |
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Email:
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takehara@med.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Graduate School of Medical Science Department of Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
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Health Condition(s) or Problem(s) studied
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Systemic/cutaneous lupus erythematosus Sjogren's syndrome
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Intervention(s)
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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.
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Primary Outcome(s)
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Change of size and/or color of erythematous lesion Patient satisfaction assessed by visual analog scale
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Secondary Outcome(s)
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Assessment for safety
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2015 |
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URL:
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