UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027663 |
|---|---|
| Receipt number | 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 | 2020/06/10 14:01:22 |
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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
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
Laboratory of medical safety management, Faculty of Pharmaceutical Sciences, 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
Kudanzaka 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
| 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
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
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031689
