UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011016
Receipt No. R000012897
Scientific Title Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer
Date of disclosure of the study information 2013/06/22
Last modified on 2014/12/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer
Acronym Ivermectin partial body bath test for healthy adults
Scientific Title Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer
Scientific Title:Acronym Ivermectin partial body bath test for healthy adults
Region
Japan

Condition
Condition scabies
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to verify the safety and efficacy of the Ivermectin whole body bath method, this study is designed to examine the effect of difference in temperature/ soaking time/ bath agent on the concentration of Ivermectin transited to horny layer by bathing forearm in Ivermectin solution.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Effects of difference in temperature/ soaking time/ bath agent on the concentration of Ivermectin transited to horny layer
Key secondary outcomes Identification of adverse events by examined drug

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 Prepare the Ivermectin whole body bath solution by melting a half tablet of Stromectol® 3mg per 10 liters of hot water (in which baby bath agent is added). This solution is used for partial body bathing.
Partial body bath test is conducted five times; two of them are for investigating soaking time; two of them are for investigating bath agent; one of them is for identifying the effect of elapsed time after bathing.
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&reg; Tablets or the charge of baby purification (Pigeon, Inc.)
9) The woman, the child below 15 km who have become pregnant
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 10

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
Email

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
Email komo1207@rs.noda.tus.ac.jp

Sponsor
Institute Tokyo University of Science
Institute
Department

Funding Source
Organization Tokyo University of Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 22 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 03 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 21 Day
Last follow-up date
2013 Year 12 Month 21 Day
Date of closure to data entry
2013 Year 12 Month 21 Day
Date trial data considered complete
2013 Year 12 Month 21 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 22 Day
Last modified on
2014 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.