UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053464 |
|---|---|
| Receipt number | R000060966 |
| Scientific Title | Randomised, parallel-group study to compare the efficacy of jigger lotion versus potassium permanganate for the treatment of tungiasis in children in Vihiga County, Kenya |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/01/28 18:35:38 |
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Basic information
Public title
Comparative study on jigger lotion versus potassium permanganate for the treatment of tungiasis in children in Vihiga County, Kenya
Acronym
Comparison of jigger lotion versus potassium permanganate for tungiasis in Kenya
Scientific Title
Randomised, parallel-group study to compare the efficacy of jigger lotion versus potassium permanganate for the treatment of tungiasis in children in Vihiga County, Kenya
Scientific Title:Acronym
Randomised, clinical study to compare jigger lotion versus potassium permanganate for tungiasis in children in Kenya
Region
| Africa |
Condition
Condition
Tungiasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if jigger lotion is superior to KMnO4 solution for topical treatments for tungiasis in school-age children in Vihiga, Kenya
To assess the safety of jigger lotion and KMnO4 solution in children with tungiasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Treatment-induced change (improvement or deterioration) in the skin condition affected by tungiasis within 2 weeks
Key secondary outcomes
Development of adverse events/effects and symptomatic improvements within 2 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Jigger lotion one or two times
Interventions/Control_2
0.05% potassium permanganate (KMnO4) solution, only once at the beginning
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged three or older age with an established diagnosis of tungiasis with stage II or IIIa based on rapid assessment by Fortaleza classification, which describes flea viability signs such as pulsation of the abdomen, expulsion of eggs, and excretion of a faecal thread.
Key exclusion criteria
or more fleas, and any disability preventing active cooperation in the study and those who have received treatment four weeks before the intervention and allergic to any of the treatments studied will be excluded. The severe cases will be referred to the Subcounty or County hospital for further clinical treatment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamiya |
Organization
Nagasaki University
Division name
School of Tropical Medicine and Global Health
Zip code
8528523
Address
1-12-4 Sakamoto, Nagasaki-city, Nagasaki
TEL
+81958197891
ykami@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamiya |
Organization
Nagasaki University
Division name
School of Tropical Medicine
Zip code
8528523
Address
1-12-4 Sakamoto, Nagasaki-city, Nagasaki
TEL
+81958197891
Homepage URL
ykami@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Yasuhiko Kamiya
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki-city, Nagasaki
Tel
0958197891
ykami@nagasaki-u.ac.jp
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
| 2024 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060966
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
