UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026867
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

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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(Trial in Honsyu).

Acronym

Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).

Scientific Title

Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).

Scientific Title:Acronym

Clinical Trial of the efficacy and safety of topical phenothrin lotion and ivermectin lotion for head lice infestations(Trial in Honsyu).

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

Interventional


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 years from May, 2017
(2)Study drug and the number of doses;Three times application of sumithrin lotion 5% .

Interventions/Control_2

(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%.

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 or person

Institute

Tokyo university of science

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 20 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

2017 Year 04 Month 20 Day

Date of IRB

2017 Year 03 Month 03 Day

Anticipated trial start date

2017 Year 04 Month 20 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 05 Day

Last modified on

2019 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030830


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name