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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016170
Receipt No. R000018527
Scientific Title Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations.
Date of disclosure of the study information 2015/01/09
Last modified on 2017/01/31

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Basic information
Public title Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations.
Acronym Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations.
Scientific Title Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations.
Scientific Title:Acronym Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin 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 We examine efficacy and safety of phenothrin lotion 5% for the topical treatment of scabies for head lice infestations.
In addition,if phenothrin lotion 5% resistance in head lice, we change ivermectin lotion 0.5% approved in FDA.We confirm to be efficacy and safety for phenothrin resistant head lice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The percentage of patients who were not observed of head louse(regardless of life or death) after application of test drugs(cure rate).
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 (1)Term;It is planned three months from July, 2015
(2)Study drug and the number of doses;Twice application of sumithrin lotion 5% .
Interventions/Control_2 (1)Term;It is planned three months from July, 2015
(2)Study drug and the number of doses;First application is sumithrin lotion 5% and second application is Sklice lotion 0.5%.
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)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.
(3)A patient who does not have other medical treatments to head lice infestations during this research participation.
(4)A patient who does not cut and are not treated with a chemical like coloring and perm during this research participation.
Key exclusion criteria (1)A patient who has obstacle of a barrier of skin by head skin diseases.
(2)A patient who has the following disease.
The disease which can have an effect on test outcome judged by a test doctor in attendance, or the disease which can have a bad effect by application of phenothrin or ivermectin.
(3)A patient with the medical history which is sensitivity to the components of sumithrin lotion 5% or Sklice lotion 0.5%,other pediculicides,insecticides ,hair care goods.
(4)A patient who received treatments for head lice infestations(OTC, home remedy, prescription)in the last 4 weeks.
(5)A female who is pregnant, possibility of pregnancy,nursing.
(6)Drugs and alcohol abuser.
(7)Illegal drugs addict.
(8)A patient who participated in a clinical trial in the last 4 weeks.
(9)A patient who judged by a test doctor in attendance to be unsuitable as a subject.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayo Komoda
Organization Division of pharmacy,
Faculty of Pharmaceutical Sciences,
Tokyo university of science
Division name Department of medical safety
Zip code
Address 2641 Yamazaki,Noda-shi, Chiba
TEL 04-7121-4134
Email komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayo Komoda
Organization Division of pharmacy,Faculty of Pharmaceutical Sciences, Tokyo university of science
Division name Department of medical safety
Zip code
Address 2641 Yamazaki,Noda-shi,Chiba
TEL 04-7121-4134
Homepage URL
Email komo1207@rs.noda.tus.ac.jp

Sponsor
Institute Tokyo university of science
Institute
Department

Funding Source
Organization Tokyo university of science
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
Address
Tel
Email

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 琉球大学医学部皮膚科 上里博(医師)
琉球大学医学部皮膚科 高橋健造(医師)
琉球大学医学部皮膚科 山口さやか(医師)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 09 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 Completed
Date of protocol fixation
2015 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 09 Day
Last modified on
2017 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018527

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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