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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-UMIN000012420 |
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Date of registration:
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27/11/2013 |
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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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Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex.
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Scientific title:
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Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex. - Clinical trial for development of OSD-001 for skin lesions due to tuberous sclerosis complex. |
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Date of first enrolment:
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2013/12/10 |
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Target sample size:
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36 |
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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=R000014541 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase I,II
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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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Mari Wataya-Kaneda |
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Address:
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2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
Japan |
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Telephone:
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06-6879-3031 |
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Email:
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mkaneda@derma.med.osaka-u.ac.jp |
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Affiliation:
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Graduate School of Medicine, Osaka University Department of Dermatology |
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Name:
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Mari Wataya-Kaneda |
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Address:
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2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
Japan |
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Telephone:
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06-6879-3031 |
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Email:
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mkaneda@derma.med.osaka-u.ac.jp |
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Affiliation:
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Graduate School of Medicine, Osaka University Department of Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients who cannot carry out this treatment plan or follow-up assessment. 2) Patients who have serious skin lesions such as erosions or ulcers. 3) Patients who have allergy to macrolide antibiotics. 4) Patients who received sirolimus, everolimus or temsirolimus administration within twelve months prior to the study entry. 5) Patients who received topical treatment of tacrolimus, vitamin D or steroid within three months prior to the study entry. 6) Patients who received laser therapy or surgical therapy within six months prior to the study entry. 7) Patients during pregnancy or lactation. 8) Patients who were judged unsuitable for this clinical trial by the investigator.
Age minimum:
3years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Tuberous sclerosis complex
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Intervention(s)
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0.05% Sirolimus gel(adult)
0.1% Sirolimus gel(adult)
0.2% Sirolimus gel(adult)
0.05% Sirolimus gel(children)
0.1% Sirolimus gel(children)
0.2% Sirolimus gel(children)
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Primary Outcome(s)
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Changes in color and size of skin lesions at 12 weeks
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Secondary Outcome(s)
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Global improvement rating Patients satisfaction
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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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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16/07/2014 |
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URL:
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