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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027663
Receipt No. R000031689
Scientific Title Clinical trial about the factor affect efficacy for treatment of scabies.
Date of disclosure of the study information 2017/06/06
Last modified on 2017/06/06

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Basic information
Public title Clinical trial about the factor affect efficacy for treatment of scabies.
Acronym A research of the efficacy for treatment of scabies.
Scientific Title Clinical trial about the factor affect efficacy for treatment of scabies.
Scientific Title:Acronym A research of the efficacy for treatment of scabies.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy for treatment of hyperkeratotic scabies by medical information and concentration of ivermectin in stratum corneum
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Medical examination (medical history, medication history, age, gender, medication, combined drugs,case report, and laboratory blood test data)
Key secondary outcomes Concentration of ivermectin in stratum corneum

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patient diagnosed as scabies
-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 Not applicable
Target sample size 30

Research contact person
Last 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
1st 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 Laboratory of medical safety management, Faculty of Pharmaceutical Sciences, Tokyo University of Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tsubasa clinic
Kudanzaka hospital
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
2017 Year 06 Month 06 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 06 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=R000031689

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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