Epidemiologic indices and comparative efficacy of Parasidose shampoo 0.2% and Dimeticone lotion 4% with Permethrin shampoo 1% in the treatment of head lice in female primary school students
This is a double blind field trial to compare the efficacy of three treatment protocols to combat head lice among female students in 7 elementary schools in the city of Kavar in Fars Province from May 2017 to August 2017. This is done using a finely-toothed plastic lice detection comb (Hedrin). For infestation with live head lice, people are screened and then put 75 patients into three groups of 25 patients; the efficacy of Parasidose shampoo 0.2% and Dimethicone lotion 4% with permethrin shampoo 1% is investigated.
Inclusion criteria: involves girls between the ages of 6 to 13 years old possessing their overall health.
Exclusion criteria: includes basic problems in the last 4 weeks, such as susceptibility to the product; skin disorders; secondary bacterial infection; Favism; scalp burn; asthma; hair dye use; bleach; gel or oil.
leaving patients from the study even after treatment at any time. Epidemiologic indices and primary and secondary outcome as well as through the questionnaire will be considered, such as the prevalence of head lice, hair length, hair status and itching. Each volunteer for the presence of lice within two weeks of treatment on days 2, 6, 9, 14 to be followed up. comparison of the measured outcomes after therapeutic intervention in three groups will be analyzed using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041627408N1
Registration date:2017-08-21, 1396/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Hadi Kalari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3835 3662
Email address
dpt2371990396@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-04, 1396/02/14
Expected recruitment end date
2017-08-05, 1396/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Epidemiologic indices and comparative efficacy of Parasidose shampoo 0.2% and Dimeticone lotion 4% with Permethrin shampoo 1% in the treatment of head lice in female primary school students
Public title
Study of the comparative efficacy of Parasidose 0.2% shampoo and Dimeticone 4% lotion with Permethrin 1% shampoo for the treatment of head louse infestation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: involves girls between the ages of 6 to 13 years old possessing their overall health.
Exclusion criteria: includes basic problems in the last 4 weeks, such as susceptibility to the product; skin disorders; secondary bacterial infection; Favism; scalp burn; asthma; hair dye use; bleach; gel or oil. leaving patients from the study even after treatment at any time.
Age
From 6 years old to 13 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NA
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.SUMS.REC.1396.24
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
The infestation rate of head lice
Timepoint
Follow-up within two weeks of starting treatment at days 2, 6, 9, 14.
Method of measurement
Hedrin comb
Secondary outcomes
1
Description
Itching Scalp
Timepoint
Follow-up within two weeks of starting treatment at days 2, 6, 9, 14.
Method of measurement
Qualitative questionnaire
Intervention groups
1
Description
First intervention group: Formulation of Permethrin 1% shampoo on a 25 person group from females during 2 weeks in 2 turns, each turn treat the scalp with it for 20 minutes.
Category
Treatment - Other
2
Description
Third intervention group: Formulation of Dimethicone 4% lotion on a group of 25 person from elementary females during 2 weeks in 2 turns, in each turn treat the scalp with it for 8 hours.
Category
Treatment - Other
3
Description
Second intervention group: Formulation of Parasidose 0.2% shampoo on a group of 25 person from elementary females during 2 weeks in 2 turns, in each turn treat the scalp with it for 8 hours.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Nemati primary school
Full name of responsible person
Mrs. Maryam Ghorbani
Street address
AL-Zahra Street, Emam Khomeyni Blvd., Kavar city, Fars
City
Kavar
2
Recruitment center
Name of recruitment center
Sajedeh primary school
Full name of responsible person
Mrs. Sara Yaghoot
Street address
Golzar (kavar Kohneh), Emam Khomeyni Blvd., Kavar city, Fars
City
Kavar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
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
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
Hadi Kalari
Position
Msc. Candidate for Medical Entomology
Other areas of specialty/work
Street address
School of Health, Razi Blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 917 737 8170
Fax
Email
dpt2371990396@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Health
Full name of responsible person
Mohammad Djaefar Moemenbellah-Fard
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Health Sciences, Institute of Health, Department of Medical Entomology and Vector Control, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
momenbf@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Mahmoudi
Position
Public Health instructor
Other areas of specialty/work
Street address
Health Center, Emam Khomeyni Blvd., Kavar, Iran
City
Kavar
Postal code
Phone
+98 71 3782 9135
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)