Comparison of the effect of Dimethicone losion with Permitrin shampoo in the treatment of pediculosis in children referred to the children's clinic in Bahar Hospital of Shahroud, a clinical trial
Comparison of the effect of Dimethicone losion with Permitrin shampoo in the treatment of head lice in children
Design
A randomized, triple blind clinical trial, based on children with head lice, which has two parallel groups.
Settings and conduct
The incidence of lice in developing countries is very high at school ages. Of all types of lice, the type of head is more common in children aged 3-12 years old and difficult to control. Many medicines are used to treat head lice, each of which has advantages and disadvantages. Recently, in some studies, the effect of Dimethicone losion on the treatment of head lice has been mentioned, which, in addition to the very good effect, is also very healthy in terms of side effects. Due to the very high prevalence of lice, especially head lice among primary school children, and the need for an effective, safe and safe drug, this study is necessary.This study is a randomized controlled clinical trial that doing in Bahar Hospital of Shahroud.
Participants/Inclusion and exclusion criteria
136 children with head lice who did not have allergic to anti-lice drugs and who did not use them during the last month are included in the study.
Intervention groups
In the intervention group, Dimethicone losion 4% was used to evaluate its effectiveness in head lice. In the control group, Permitrin shampoo 1% was used for the treatment of head lice.
Main outcome variables
The rate of head lice and head itching in the beginning of the study, 7 and 14 days after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N14
Registration date:2018-11-12, 1397/08/21
Registration timing:registered_while_recruiting
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dimethicone losion with Permitrin shampoo in the treatment of pediculosis in children referred to the children's clinic in Bahar Hospital of Shahroud, a clinical trial
Public title
Comparison of the effect of Dimethicone losion with Permitrin shampoo in the treatment of pediculosis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children infected with head lice;
Age 3 to 12 years;
Having general health;
Parental Satisfaction for Child Participation in the Plan;
Exclusion criteria:
Having autoimmune disease;
Having a history of asthma
History of using anti-convulsion drugs
Use of anti-lice drugs in a recent month
Having a scalp wound or scalp burning
Having tumors of the scalp
Parental no satisfaction for Child Participation in the Plan;
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participant, antecedents of the outcome evaluation, and analyzer are blinded.The division of patients into two groups A and B is done by a qualified person who has no knowledge of the actions performed in the two groups. Do experiments and results recorder will be done by a qualified person without any knowledge of the type of medicine and patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Research Deputy; Shahroud University of Medical Sciences; Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.SHMU.REC.1397.034
Health conditions studied
1
Description of health condition studied
Head lice
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
Improvement based on the absence of adult lice, nymphs and lambs (Rashke)
Timepoint
At the beginning of the study, 7 and 14 days after the treatment
Method of measurement
Examination of children with magnifying by a pediatrician
Secondary outcomes
1
Description
Measuring the level of itching of the scalp
Timepoint
At the beginning of the study, 7 and 14 days after the treatment
Method of measurement
Use the Visual Analogue Scale to measure the itching
Intervention groups
1
Description
Intervention group: After providing the necessary training for parents (mothers) regarding the correct use of Dimethicone lotion, between 10-8 cc of Dimethicone 4% fully covered on all hair of the head, which is slightly dull, rubbed and washed completely after 12-8 hours.Then with the help of a toothed shoulder, all hair parts are fully and at least for 15 minutes was teazled and the same treatment is repeated exactly the next week.
Category
Treatment - Drugs
2
Description
Control group: After providing the necessary training for parents (mothers) regarding the correct use of Permetrin shampoo, between 10-8 cc of Permetrin 1% fully covered on all hair of the head, which is slightly dull, rubbed and washed completely after 12-8 hours.Then with the help of a toothed shoulder, all hair parts are fully and at least for 15 minutes was teazled and the same treatment is repeated exactly the next week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Dr. Afsane Sadeghian
Street address
Bahar Hospital; 22 Bahman Street
City
Shahroud
Province
Semnan
Postal code
3616698881
Phone
+98 23 3222 6173
Fax
+98 23 3222 6174
Email
afsanesadeghian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Research deputy; Shahroud University of Medical Sciences; Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The personal budget of researchers
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Bagher Sohrabi
Position
Educational Manager of Medical Faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
mb.sohrabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Pouyan Kianian
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar Hospital; 22 Bahman Street
City
Shahroud
Province
Semnan
Postal code
3616698881
Phone
+98 23 3222 6173
Fax
+98 23 3222 6174
Email
p_kianian95@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Pouyan Kianian
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar Hospital; 22 Bahman Street
City
Shahroud
Province
Semnan
Postal code
3616698881
Phone
+98 23 3222 6173
Fax
+98 23 3222 6174
Email
p_kianian95@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available