Comparing the efficacy of permethrin 1% and dimethicone 4% in treatment of head lice infestation.
Design
This study is a double blind randomized clinical trial (phase 4)carried out among 90 patients with pediculosis infestation. These patients will be randomly allocated to permethrin 1% and dimethicone 4% treatment groups. Using random allocation software, 15 blocks of six will be prepared and subjects will be entered into the trial based on these blocks.
Settings and conduct
The study is conducted among primary school girls in Goloughah, Mazandaran province.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Female gender, age between 6 and 13 years, being infected with head lice and having normal general condition. Exclusion criteria : History of any sensitivity to anti-pediculosis drugs, dermatologic disorders, secondary bacterial infection, scalp burning, asthma, using hair care products, using anti-pediculosis drugs during the last seven days.
Intervention groups
Group 1 intervention: Lotion dimethicone 4% will be rubbed on the hairs from the root to the top.
Group 2 intervention: The total surface of the sculp and hairs will be pealed With appropriate amount of permethrin 1% .
Main outcome variables
Cure rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171117037512N2
Registration date:2018-02-22, 1396/12/03
Registration timing:registered_while_recruiting
Last update:2018-02-22, 1396/12/03
Update count:0
Registration date
2018-02-22, 1396/12/03
Registrant information
Name
Mahmood Moosazadeh
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 9562
Email address
mmoosazadeh1351@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-03-15, 1396/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of permethrin 1% and dimethicone 4% in treatment of primary school girls with head lice infestation: a clinical trials
Public title
Comparing the efficacy of permethrin and dimethicone in treatment of head lice infestation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
age between 6 and 13 years
being infected with head lice
having normal general condition
Exclusion criteria:
History of any sensitivity to anti-pediculosis drugs
Dermatologic disorders
Secondary bacterial infection
Scalp burning
Asthma
Using hair care products
Using anti-pediculosis drugs during the last seven days
Age
From 6 years old to 13 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double blind randomized clinical trial carried out among 90 patients with pediculosis infestation. These patients will be allocated to permethrin 1%(Gilaranco, Rasht, Iran) and dimethicone 4%(Salmi Daru co, Tehran, Iran, IRC: 1228136177) treatment groups using block randomization by means of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both drugs will be covered with similar boxes for blinding reason.This action is enough to blind patients because the shampoo is consumed at home. The outcome evaluators will also be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran-Sari
City
Sari
Province
Mazandaran
Postal code
7678948516
Approval date
2015-10-05, 1394/07/13
Ethics committee reference number
1488
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
Cure rate in each group as no evidence of any adult lice, nymph or egg.
Timepoint
Before intervention, days 7, 14 and 21.
Method of measurement
Examination of samples by an expert medical entomologist
Secondary outcomes
1
Description
Dermal and periorbital allergic reactions.
Timepoint
Before intervention, days 7, 14 and 21.
Method of measurement
Sample examination
Intervention groups
1
Description
Group 1 intervention: In the treatment group with dimethicone, lotion dimethicone 4% will be pealed around the hairs from the root to the top. It should be normally dried and stayed at least eight hours or one night.
Category
Treatment - Drugs
2
Description
Control group: In the treatment group with permethrin 1%, first, hairs will be washed by another shampoo and dried. Then, all hairs as well as the scalp should be completely covered with appropriate amount of permethrin 1% shampoo for 10 minutes and then, will be washed with water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School
Full name of responsible person
Mahmood Moosazadeh
Street address
Moallem square, research deputy
City
Ghaloughah
Province
Mazandaran
Postal code
4851676789
Phone
+98 11 3448 4800
Email
mmoosazadeh1351@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid saeedi
Street address
Moallem Squre-research deputy
City
Sari
Province
Mazandaran
Postal code
4851676789
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmood Moosazadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Moallem square-sari
City
Sari
Province
Mazandaran
Postal code
4851676789
Phone
+98 11 3325 7230
Fax
Email
mmoosazadeh1351@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmood Moosazadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4851676789
Phone
+98 11 3325 7230
Fax
Email
mmoosazadeh1351@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmood Moosazadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Moallem square, research deputy
City
Sari
Province
Mazandaran
Postal code
4851676789
Phone
+98 11 3448 4800
Fax
Email
mmoosazadeh1351@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared.
When the data will become available and for how long
After publishing the results.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
To be applied as a data bank for IPD meta-analysis.
From where data/document is obtainable
Via e-mail to corresponding author
mmoosazadeh1351@gmail.com
What processes are involved for a request to access data/document