UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013068 |
|---|---|
| Receipt number | R000015246 |
| Scientific Title | Experimental study of the serum and horny layer concentration shift in Ivermectin bath method |
| Date of disclosure of the study information | 2014/02/04 |
| Last modified on | 2017/06/06 17:46:28 |
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Basic information
Public title
Experimental study of the serum and horny layer concentration shift in Ivermectin bath method
Acronym
Ivermectin bath trail for healthy adults
Scientific Title
Experimental study of the serum and horny layer concentration shift in Ivermectin bath method
Scientific Title:Acronym
Ivermectin bath trail for healthy adults
Region
| Japan |
Condition
Condition
scabies
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify the safety and efficacy of the Ivermectin bath method, this study is designed to examine the concentration of Ivermectin in both blood and horny layer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-The concentration of Ivermectin in horny layer
-The concentration of Ivermectin in blood
Key secondary outcomes
-The concentration of Ivermectin in the bath solution
-Toxic Epidermal necrosis
-Stevens-Johnson syndrome
-Impairment of liver function
-Other adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
After preparing Ivermectin bath solution that 4 tablets of Stromectol put into 150 liters of hot water with baby bath agent, volunteer takes the bath for from 5 to 15minutes. Then, the state of the skin is observed for one week.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy and over age of 20
2) Have written consent on subjects' free will after being completely explained about this study
Key exclusion criteria
1) The patient who has an obstacle in the barrier of the skin according to a skin disorder
2) Those who have the following diseases in the past or the present
- Liver disease
- The disease considered to affect a test result by a doctor in attendance in addition to this, or the disease considered that medication of ivermectin brings about a disadvantage
3) The superfluous ingestion person of the coffee containing caffeine, or a drink (>8 cup / day)
4) The abuse person of medicine or alcohol
5) The addict of an illegal drug
6) The woman who offered the blood of 400mL within the man and woman who offered the blood of 200mL within four weeks before the examination or the man who offered the blood of 400mL within 12 weeks, and 16 weeks
7) Those who participated in four weeks to the clinical test using other investigational new drugs before this start of test
8) Those who have an anamnesis of hypersensitivity in the ingredient of a StromectolⓇ Tablets or the charge of baby purification (Pigeon, Inc.)
9) The woman during pregnancy or potential pregnancy, and breast-feeding
10) Those whom the examination doctor in attendance judged to be unsuitable as a subject
11) Those who have used medication within a week
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Komoda |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-4134
komo1207@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Komoda |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-4134
Homepage URL
komo1207@rs.noda.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kikkoman General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015246
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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