This investigation is conducted to evaluate two treatment methods on head lice among female primary school students of Larestan in south east of Fars province, Iran. In this cross sectional survey, formulations of lindane 1% and permethrin 1% shampoos are used on two groups of 40 girls, respectively, who are treated for live head lice after screening with the aid of plastic lice detection combs (Hedrin) at 13 female primary schools of Larestan. Inclusion criteria comprises of being female at age 6 to 13 and generally healthy. Exclusion criteria also considered as being at any other treatment procedure for pediculosis. A questioner form on some epidemiologic factors was also included. The outcomes such as head lice infestation level, hair length, hair style and itching, will be followed up for two weeks from initial treatment on days 2, 6, 9 and 14. Data obtained from measurements after intervention in both groups will be compared by SPSS software analyzing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010816372N2
Registration date:2015-01-25, 1393/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Farzad Nikaein
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1726 2850
Email address
nikaeinf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Expected recruitment start date
2013-10-10, 1392/07/18
Expected recruitment end date
2013-12-10, 1392/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of 1% permethrin with 1% lindane in the treatment of head lice in female primary school students
Public title
Assessment of efficacy of 1% permethrin in treatment of head lice in female primary school students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria comprises of being female at age 6 to 13 and generally healthy. Exclusion criteria also considered as being at any other treatment procedure for pediculosis.
Age
From 6 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Commitee
Street address
Shiraz University of Medical Sciences Ethics Commitee, Zand st., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
92-6876
Health conditions studied
1
Description of health condition studied
Pediculosis
ICD-10 code
B85.0
ICD-10 code description
Head-louse infestation
Primary outcomes
1
Description
Head lice infestation
Timepoint
Followed up for two weeks from initial treatment on days 2, 6, 9 and 14
Method of measurement
plastic lice detection combs (Hedrin)
Secondary outcomes
1
Description
Itching
Timepoint
Followed up for two weeks from initial treatment on days 2, 6, 9 and 14
Method of measurement
Qualitative questionaire
Intervention groups
1
Description
Intervention group 1: Formulations of lindane 1% shampoos were used on a group of 40 girls in form of 4 courses during 2 weeks, 5 minutes topical administration each course
Category
Treatment - Other
2
Description
Intervention group 1: Formulations of permethrin 1% shampoos will be used on a group of 40 girls in form of 4 courses during 2 weeks, 5 minutes topical administration each course
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Primary School
Full name of responsible person
Mrs. Zeynab Mohebi
Street address
Shahid Sodoghi St., Lar city, Fars, Iran
City
Larestan
2
Recruitment center
Name of recruitment center
Somayeh Primary School
Full name of responsible person
Mrs. Mahin Alipoor
Street address
Emam Khomeyni St., Lar city, Fars, Iran
City
Larestan
3
Recruitment center
Name of recruitment center
Boostan Primary School
Full name of responsible person
Mrs. Zahra Mohhamadi
Street address
Hejab St., Lar city, Fars, Iran
City
Larestan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Full name of responsible person
Dr. Ali Poostforush
Street address
Vice Chancellor for Research Affairs, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Health, Shiraz University of Medical Sciences
Full name of responsible person
Zahra Nasiri
Position
Msc. Candidate for Nutrition
Other areas of specialty/work
Street address
School of Health, Razi blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 1000
Fax
Email
farzad.nikaein@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Health, Department of Medical Entomology, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Djaefar Moemenbellah-Fard
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health, Razi Blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 1000
Fax
Email
nikaeinf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzad Nikaein
Position
BSc. Nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
nikaeinf@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)