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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-UMIN000021030 |
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Date of registration:
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22/02/2016 |
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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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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of OSD-001 in patients with Neurofibromatosis type 1
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of OSD-001 in patients with Neurofibromatosis type 1 - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of OSD-001 in patients with Neurofibromatosis type 1 |
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Date of first enrolment:
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2016/03/16 |
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Target sample size:
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18 |
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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=R000024265 |
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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 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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06-6879-5111 |
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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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06-6879-5111 |
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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 received radiotherapy or neutron capture therapy on skin lesions within 12 months prior to enrollment. 2) Patients who have received surgical therapy on skin lesions within 6 months prior to enrollment. 3) Patients who treated with sirolimus, everolimus or temsirolimus (mTOR inhibitors), within 6 months prior to enrollment. 4) Patients who received topical treatment of tacrolimus within 3 months prior to enrollment. 5) Patients who have severe complications such as cardiac disease, liver disease, pulmonary disease, hematological disorder . 6) Patients who have previously experienced alcoholic sensitivity or allergy to sirolimus. 7) Patients who are pregnant or lactating. 8) Patients who have entered another clinical trial within 6 months prior to enrollment.
Age minimum:
16years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis type 1
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Intervention(s)
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0.2% Sirolimus gel twice daily 24 weeks topical application
0.4% Sirolimus gel twice daily 24 weeks topical application
Placebo gel twice daily 24 weeks topical application
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Primary Outcome(s)
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Changes from baseline in the size of cutaneous tumor (CT scan) after 24 week treatment
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Secondary Outcome(s)
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1. Changes from baseline in the size of cutaneous tumor (measured by ruler) after 24 week treatment 2. Improvements of cutaneous lesions after 12 or 24 week treatment 3. Histopathological evaluation of cutaneous tumor after 24 week treatment 4. Evaluation of Dermatology Life Quality Index (DLQI) after 12 or 24 week treatment
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development
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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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20/01/2017 |
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URL:
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