Unique ID issued by UMIN | UMIN000008994 |
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Receipt number | R000010550 |
Scientific Title | Clinical trial for identifying the safety of the Ivermectin bath method. |
Date of disclosure of the study information | 2012/09/27 |
Last modified on | 2016/08/07 15:06:41 |
Clinical trial for identifying the safety of the Ivermectin bath method.
The Ivermectin bath method
Clinical trial for identifying the safety of the Ivermectin bath method.
The Ivermectin bath method
Japan |
scabies
Dermatology |
Others
NO
Verifying the safety of Ivermectin bath method as a new treatment for scabies.
Safety
Exploratory
Pragmatic
Not applicable
Monitoring the early symptoms of adverse effects of the Ivermectin bath method as its safety assessment.
Analysis of Ivermectin concentration in stratum corneum and blood after the use of Ivermectin bath method.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
As a preparation for the use of Ivermectin bath method, 4 tablets of Stromectol Tablets 3mg is dissolved in baby bath powder contained hot tub water of 150L. Then, one takes a bath in the prepared tub water.
The second trial (same preparation as the first trial) is carried out after 7days. 22days of blank period for observation is implemented after the second trial.
20 | years-old | <= |
Not applicable |
Male and Female
- Patient diagnosed as scabies
- Patient who belongs in a care service facility of a medical monitoring by specialized physician
- Patient who signed, based on his/her free will, to the clinical trial agreement with full understanding of the purpose of this conducted trial and its insights.
1) Patient diagnosed with a skin disorder and thus has skin barrier problem
2) One who has had the experience of the following;
- Hepatic disease
- The disease considered to affect the test results by doctor in attendance.
- The disease considered that use of Ivermectin results detrimental to the patient.
3) one with excessive consumption of caffeine contained coffee or drink (>8 cups / day)
4) abuser of medication or alcohol
5) The addict of an illegal drug
6) One who has contributed 200mL blood within 4 weeks before the trial, or male contributed 400mL blood within 12 weeks and female contributed 400mL blood within 16 weeks
7) One who participated in other clinical trials with the use of study medication within 4 weeks before the trial
8) One who has an anamnesis of hypersensitivity for the ingredients contained in Stromectol Tablets or in the baby bath powder (Pigeon, Inc.)
9) Pregnant female or lactating woman or child under 15kg weight
10) One whom the doctor considered to be unsuitable for this clinical trial
6
1st name | |
Middle name | |
Last name | Masayo Komoda |
Tokyo University of Science
Faculty of Pharmaceutical Sciences
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
04-7121-4134
komo1207@rs.noda.tus.ac.jp
1st name | |
Middle name | |
Last name | Masayo Komoda |
Tokyo University of Science
Faculty of Pharmaceutical Sciences
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
04-7121-4134
komo1207@rs.noda.tus.ac.jp
Laboratory of medical safety
management, Tokyo University of Science
None
Self funding
Tsubasa clinic
NO
2012 | Year | 09 | Month | 27 | Day |
Unpublished
Completed
2012 | Year | 06 | Month | 15 | Day |
2012 | Year | 09 | Month | 27 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 27 | Day |
2016 | Year | 08 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010550
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