UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations.
Title of the study (Brief title)	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	Masayo Komoda
Organization	Division of pharmacy, Faculty of Pharmaceutical Sciences, Tokyo university of science
Division name	Department of medical safety
Address	2641 Yamazaki,Noda-shi, Chiba
TEL	04-7121-4134
Email	komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person	Masayo Komoda
Organization	Division of pharmacy,Faculty of Pharmaceutical Sciences, Tokyo university of science
Division name	Department of medical safety
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018527