UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043440 |
|---|---|
| Receipt number | R000048428 |
| Scientific Title | Efficacy and safety of a Dimethicone lotion for head lice infestations. |
| Date of disclosure of the study information | 2021/05/16 |
| Last modified on | 2021/02/25 19:14:49 |
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Basic information
Public title
Efficacy and safety of a Dimethicone lotion for head lice infestations.
Acronym
Efficacy and safety of a Dimethicone lotion for head lice infestations.
Scientific Title
Efficacy and safety of a Dimethicone lotion for head lice infestations.
Scientific Title:Acronym
Efficacy and safety of a Dimethicone lotion for head lice infestations.
Region
| Japan |
Condition
Condition
Head lice infestations
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, we only use phenothrin shampoo and powder for head lice infestations, and that cause serious resistance for those pesticides, especially in Okinawa.
We confirm to be efficacy and safety of a new type of head lice treatment, dimethicone lotion for phenothrin resistant head lice in Okinawa.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase III
Assessment
Primary outcomes
The percentage of cured patients, remove of live head louse and live eggs, after 3 times treatments per week of dimethicone lotion.
Key secondary outcomes
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 |
Interventions/Control_1
Self-treatment of dimethicone lotion, 3 times per week.
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
| 6 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) More than 6-month-old patient who was received a diagnosis of head lice infestations.
(2) Among head lice infestation patients, 1 or more head lice infestation (survivable individuals including adults and larvae) or 20 or more eggs (all eggs including hatched and unhatched eggs) by visual confirmation for 3 minutes. Those who could confirm.
(3) A patient who understood sufficiently and done voluntary documentary agreement by subject or legal representative after a sufficient explanation. But if a subject is more than 16 years old and less than 20 years old,we must get a nod from a subject after agreement of legal representative.
Key exclusion criteria
(1) A patient who has obstacle of a barrier of skin by head skin diseases.
(2) Those who need administration of antibiotics and hormones.
(3) Persons with the medical history which is sensitivity to medicines or cosmetics.
(4) Persons with liver, kidney or other complications such as serious heart / kidney / liver disorders, respiratory diseases, and cardiovascular diseases.
(5) A female who is pregnant, possibility of pregnancy,nursing.
(6) Persons who cannot discontinue administration of drugs that may affect the evaluation of the test product.
(7) Persons who have dyed, decolorized, permanently or straightened their hair within 2 weeks.
(8) Those who participated in other exams within 3 months.
(9) For patients in which no adult of larvas were confirmed and only eggs were found, the hatching rate of the collected eggs was 0%.
(10) A patient who judged by a test doctor in attendance to be unsuitable as a subject.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Iwata |
Organization
Earth corporation
Division name
Research & Development headquarters Development Dept.
Zip code
101-0048
Address
12-1, Kanda-Tsukasamachi 2-chome Chiyoda-ku, Tokyo 101-0048, Japan
TEL
03-5207-7464
iwata-yoichi@earth.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Iwata |
Organization
Earth corporation
Division name
Research & Development headquarters Development Dept.
Zip code
101-0048
Address
12-1, Kanda-Tsukasamachi 2-chome Chiyoda-ku, Tokyo 101-0048, Japan
TEL
03-5207-7464
Homepage URL
iwata-yoichi@earth.jp
Sponsor or person
Institute
Earth corporation
Institute
Department
Personal name
Funding Source
Organization
Earth corporation
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
Earth corporation
Address
12-1, Kanda-Tsukasamachi 2-chome Chiyoda-ku, Tokyo 101-0048, Japan
Tel
03-5207-7464
iwata-yoichi@earth.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
琉球大学医学部付属病院 皮膚科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 16 | 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
35
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The information will be published after the paper is published.
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
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048428
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