UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044320 |
|---|---|
| Receipt number | R000050621 |
| Scientific Title | An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2025/05/13 10:15:06 |
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Basic information
Public title
A clinical trial with two treatments of tungiasis in Homa Bay, Kenya
Acronym
A clinical trial with two treatments of tungiasis in Kenya
Scientific Title
An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya
Scientific Title:Acronym
An existing treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Kenya
Region
| Africa |
Condition
Condition
Tungiasis
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the most acceptable treatment for local treatment in children with tungiasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A difference in cure rate (embedded fleas' viability) on day 11.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dimeticone (NYDA) for the first day
Interventions/Control_2
5% sodium carbonate solution for the first day
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Children who have been infected by tungiasis in Homa Bay, Kenya
-Children who provide written consent to participate in the study (parental consent will also be required)
-Children who have one to five embedded sand flea per foot
Key exclusion criteria
-Children with secondary bacterial infection based on the established rapid diagnostic method
-Children infested with massive fleas (more than 10 fleas)
-Children / Caregivers declined to participate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Suzuki |
Organization
Nagasaki University
Division name
School of Tropical Medicine and Global Health
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
81958197583
ksuzuki@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Suzuki |
Organization
Nagasaki University
Division name
School of Tropical Medicine and Global Health
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
81958197583
Homepage URL
ksuzuki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TMGH ethics review board, Nagasaki University
Address
1-12-4, Sakamoto, Nagasaki
Tel
81958197583
tmgh_jimu@ml.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
| 2021 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2409-9279/6/1/12
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
160
Results
A total of 941 lesions from 160 participants were recruited. After excluding cases, 823 lesions from 157 participants were analyzed. Based on the findings of the pilot study, the observation period was adjusted to 11 days. The cure rates on Day 11 were 77% for a 5% sodium bicarbonate solution and 88% for silicone oil. Additionally, no significant differences were observed between the two treatments in terms of symptoms like pain and itching, or in inflammation scores.
Results date posted
| 2025 | Year | 05 | Month | 13 | Day |
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
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
One case of pain was reported in a foot treated with sodium carbonate. Upon examination by a medical doctor (MD), redness was observed, and the area was cleansed with clean water. The condition was attributed to a pre-existing cut on the child's foot, and the case was excluded from the study. Monitoring continued, and on Day 7, an MD conducted a follow-up evaluation. The child's condition was found to be good, the redness had resolved, and the lesion was confirmed to have healed.
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050621
