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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-jRCTs031180409 |
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Date of registration:
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22/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of the genetic defect of cholesterol biosynthetic pathway.
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Scientific title:
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Treatment of the genetic defect of cholesterol biosynthetic pathway by the topical application of statin and cholesterol. |
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Date of first enrolment:
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25/12/2013 |
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Target sample size:
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158 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031180409 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Akiharu
Kubo |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
160-8582
Tokyo
Japan |
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Telephone:
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+81-3-5363-3823 |
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Email:
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akiharu@a5.keio.jp |
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Affiliation:
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Department of Dermatology Keio University School of Medicine |
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Name:
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Akiharu
Kubo |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
160-8582
Tokyo
Japan |
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Telephone:
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+81-3-5363-3823 |
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Email:
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akiharu@a5.keio.jp |
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Affiliation:
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Department of Dermatology Keio University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients of CHILD syndrome or Conradi syndrome confirmed by genetic diagnosis.
Patients of atopic dermatitis, psoriasis vulgaris, seborrheic dermatitis, and porokeratosis diagnosed clinically.
Healthy subject.
Exclusion criteria: Patients without skin manifestations.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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CHILD syndrome, Conradi syndrome, porokeratosis, atopic dermatitis, psoriasis, seborrheic dermatitis
Dermatitis and eczema
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Dermatitis and eczema
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Intervention(s)
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To patients, 1% atorvastatin/ 2% cholesterol lotion and/or 1% atorvastatin/ 2% cholesterol ointment, and/or 1% oxiconazole cream are topically applied on the skin. To healthy subjects, administration of atorvastatin or topical application of 1% atorvastatin/ 2% cholesterol is performed once to investigate drug metabolism.
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Primary Outcome(s)
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Improvement of skin erythema and scales
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Secondary Outcome(s)
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Rate of common adverse events
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Secondary ID(s)
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UMIN000012355
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Source(s) of Monetary Support
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Maruho Co., Ltd.
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Ethics review
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Status: Approval
Approval date:
Contact:
med-rinri-jimu@adst.keio.ac.jp
Certified Review Board of Keio
+81-3-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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