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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043440
Receipt No. 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

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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
Email 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
Email iwata-yoichi@earth.jp

Sponsor
Institute Earth corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048428

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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