Unique ID issued by UMIN | UMIN000015114 |
---|---|
Receipt number | 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 20:57:02 |
Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex
Japan |
Tuberous sclerosis complex
Dermatology |
Others
NO
The purpose of this study is to explore the safety and the efficacy of topical rapamycin gel for skin lesions in tuberous sclerosis complex.
Safety,Efficacy
Confirmatory
Phase II,III
Improvements in redness, papule size and flatness of facial angiofibroma
Adverse events
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Application of 0.2% rapamycin gel on skin lesions of the face and trunk twice a day for 12 weeks.
Not applicable |
70 | years-old | > |
Male and Female
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
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.
24
1st name | |
Middle name | |
Last name | Mari Wataya-Kaneda |
Graduate School of Medicine, Osaka University
Department of Dermatology
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
06-6879-3031
mkaneda@derma.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Mari Wataya-Kaneda |
Graduate School of Medicine, Osaka University
Department of Dermatology
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
06-6879-3031
mkaneda@derma.med.osaka-u.ac.jp
Department of Dermatology
Graduate School of Medicine, Osaka University
Ministry of Health, Labour and Welfare
Japan
Ministry of Education, Culture, Sports, Science and Technology of Japan
NO
大阪大学医学部附属病院(大阪府)
2014 | Year | 09 | Month | 10 | Day |
Unpublished
Open public recruiting
2014 | Year | 07 | Month | 28 | Day |
2014 | Year | 09 | Month | 11 | Day |
2015 | Year | 12 | Month | 31 | Day |
2014 | Year | 09 | Month | 10 | Day |
2014 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017546