UMIN-CTR Clinical Trial

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