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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002844
Receipt No. 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

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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
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

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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