UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Experimental study of the serum and horny layer concentration shift in Ivermectin bath method
Title of the study (Brief title)	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&#9415; 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	Masayo Komoda
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7121-4134
Email	komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person	Masayo Komoda
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
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	Kikkoman General Hospital
Name of secondary funｄer(s)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015246