Unique ID issued by UMIN | UMIN000026867 |
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Receipt number | R000030830 |
Scientific Title | Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu). |
Date of disclosure of the study information | 2017/04/20 |
Last modified on | 2019/04/11 16:25:37 |
Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).
Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).
Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).
Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).
Japan |
head lice infestations
Dermatology |
Others
NO
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.
Safety,Efficacy
Exploratory
Others
Not applicable
The percentage of patients who were not observed of head louse(regardless of life or death) after application of test drugs(cure rate).
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
(1)Term;It is planned three years from May, 2017
(2)Study drug and the number of doses;Three times application of sumithrin lotion 5% .
(1)Term;It is planned three years from May, 2017
(2)Study drug and the number of doses;First application is sumithrin lotion 5% and second application is Sklice lotion 0.5%.
6 | months-old | <= |
Not applicable |
Male and Female
(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.
(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.
12
1st name | |
Middle name | |
Last name | Masayo Komoda |
Division of pharmacy,
Faculty of Pharmaceutical Sciences,
Tokyo university of science
Department of medical safety
2641 Yamazaki,Noda-shi,Chiba
04-7121-4134
komo1207@rs.noda.tus.ac.jp
1st name | |
Middle name | |
Last name | Masayo Komoda |
Division of pharmacy,Faculty of Pharmaceutical Sciences, Tokyo university of science
Department of medical safety
2641 Yamazaki,Noda-shi,Chiba
04-7121-4134
komo1207@rs.noda.tus.ac.jp
Tokyo university of science
Tokyo university of science
Other
NO
2017 | Year | 04 | Month | 20 | Day |
Unpublished
Completed
2017 | Year | 04 | Month | 20 | Day |
2017 | Year | 03 | Month | 03 | Day |
2017 | Year | 04 | Month | 20 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 04 | Month | 05 | Day |
2019 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030830
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