UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002844 |
|---|---|
| Receipt number | R000003457 |
| Scientific Title | Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex |
| Date of disclosure of the study information | 2009/12/03 |
| Last modified on | 2014/03/19 16:36:17 |
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Basic information
Public title
Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex
Acronym
Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex
Scientific Title
Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex
Scientific Title:Acronym
Development of topical treatment with rapamycin for skin lesions of 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 study is to develop an effective and safe treatment for skin lesions in tuberous sclerosis complex.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
change in color and size of the skin lesions after 12 weeks topical treatment
Key secondary outcomes
change in shape
appearance of contact dermatitis
rapamycin levels in whole blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of 0.2% Rapamycin ointment (ointment base is 0.03% tacrolimus ointment) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Interventions/Control_2
Application of 0.2% Rapamycin ointment (ointment base is white petrolatum) on skin lesion of one side of the face twice a day for 12 weeks.
Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Interventions/Control_3
Application of 0.2% Rapamycin gel (base is carboxyvinyl polymer) on skin lesion of one side of the face twice a day for 12 weeks.
Application of gel base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with a diagnosis of tuberous sclerosis complex made based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association.
2) Patients who want to receive treatment for skin lesions of tuberous sclerosis complex.
3) Patients who cannot receive other effective treatment.
4) Patients who would not want to receive surgical treatment because of social circumstances or cosmetic reasons.
Key exclusion criteria
1) Patients with severe mental retardation who cannot carry out this treatment plan.
2) Patients with a past history of hypersensitivity to macrolide antibiotics.
3) Patients who were judged unsuitable for this study by the investigator.
Target sample size
21
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 29 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 29 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003457
