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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015114
Receipt No. R000017546
Scientific Title Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Date of disclosure of the study information 2014/09/10
Last modified on 2014/09/10

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Basic information
Public title Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Acronym Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Scientific Title Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Scientific Title:Acronym Clinical study of safety and efficacy of rapamycin topical medication 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 study is to explore the safety and the efficacy of topical rapamycin gel for skin lesions in tuberous sclerosis complex.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Improvements in redness, papule size and flatness of facial angiofibroma
Adverse events
Key secondary outcomes Improvements in erythema, plaque, and white macules of the face
Improvements in shagreen patch and white macules of the trunk
The comprehensive improvement judged by doctor
Patient satisfaction
Blood level of rapamycin
Results of blood test and urinalysis

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Application of 0.2% rapamycin gel on skin lesions of the face and trunk twice a day for 12 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit
70 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 solitary angiofibromas on the face.
3) Patients who are not suitable for laser or surgical treatments, or who don't want surgical treatments.
4) Patients who or whose guardian can apply medicine as planed according to the instructions of the doctor
5) Patients who or whose guardian can give the written consent by oneself in understanding after having received enough explanation on this study.
6) Patients under 70 years old

Key exclusion criteria 1) Patients who cannot carry out this treatment plan.
2) Patients who have a severe erosion or ulcer on the lesion.
3) Patients who have allergy to macrolide antibiotics.
4) Patients who received oral administration of rapamycin (sirolimus) , everolimus or temsirolimus within 12 months prior to the study entry.
5) Patients who received topical treatment of tacrolimus within three months prior to the study entry.
6) Patients who received laser or surgical therapy to the target lesion within six months prior to the study entry.
7) Patients who have complications such as severe heart disease, liver disease, lung disease, or blood disorders, and are considered unsuitable to participate in this study.
8) Patients with alcohol intolerance.
9) Patients who are pregnant or lactating.
10) Patients who cannot agree to use effective methods of contraception during this study.
11) Patients who were judged unsuitable for this study by the investigator.


Target sample size 24

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
Email 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
Email mkaneda@derma.med.osaka-u.ac.jp

Sponsor
Institute Department of Dermatology
Graduate School of Medicine, Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology of Japan

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 09 Month 10 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 11 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2014 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017546


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