UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008994
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

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Basic information

Public title

Clinical trial for identifying the safety of the Ivermectin bath method.

Acronym

The Ivermectin bath method

Scientific Title

Clinical trial for identifying the safety of the Ivermectin bath method.

Scientific Title:Acronym

The Ivermectin bath method

Region

Japan


Condition

Condition

scabies

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verifying the safety of Ivermectin bath method as a new treatment for scabies.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Monitoring the early symptoms of adverse effects of the Ivermectin bath method as its safety assessment.

Key secondary outcomes

Analysis of Ivermectin concentration in stratum corneum and blood after the use of Ivermectin bath method.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

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.

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

- 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.

Key exclusion criteria

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

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

Email

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


Email

komo1207@rs.noda.tus.ac.jp


Sponsor or person

Institute

Laboratory of medical safety
management, Tokyo University of Science

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tsubasa clinic

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

2012 Year 09 Month 27 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

2012 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 27 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 09 Month 27 Day

Last modified on

2016 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010550


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name