UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012420 |
|---|---|
| Receipt number | R000014541 |
| Scientific Title | Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex. |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2014/12/10 16:43:15 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex.
Acronym
Clinical trial for development of OSD-001 for skin lesions due to tuberous sclerosis complex.
Scientific Title
Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex.
Scientific Title:Acronym
Clinical trial for development of OSD-001 for skin lesions due to tuberous sclerosis complex.
Region
| Japan |
Condition
Condition
Tuberous sclerosis complex
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to develop an effective and safe treatment for skin lesions due to tuberous sclerosis complex.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Changes in color and size of skin lesions at 12 weeks
Key secondary outcomes
Global improvement rating
Patients satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.05% Sirolimus gel(adult)
Interventions/Control_2
0.1% Sirolimus gel(adult)
Interventions/Control_3
0.2% Sirolimus gel(adult)
Interventions/Control_4
0.05% Sirolimus gel(children)
Interventions/Control_5
0.1% Sirolimus gel(children)
Interventions/Control_6
0.2% Sirolimus gel(children)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as tuberous sclerosis complex based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association.
2) Patients who have three or more isolated lesions of facial angiofibroma.
3) Patients to whom laser therapy or surgical therapy is not applicabie or patients who do not want to receive surgical treatments.
Key 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.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Wataya-Kaneda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3031
mkaneda@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Wataya-Kaneda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3031
Homepage URL
mkaneda@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dermatology
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2014 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014541
