Protocol summary

Summary
This double blinded randomized clinical trial will be held to compare the effects of lindane 1%., Permethrin 1% and Dimethicon 4% shampoos in the treatment of head lice infestation in girls of primary schools in Ahvaz (Autumn 2015). Study blinding will be done for patients and researchers. The sample size of the study is 442 subjects with head lice, which will be randomly chosen from students. Positive cases of pediculosis will be divided randomly into 4 equal groups. One group served as the control will use ordinary shampoo. Each group will contain 111 cases. The effects of four kinds of shampoo will be studied in different groups on days two, seven and fourteen days after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016013026266N1
Registration date: 2016-03-07, 1394/12/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Hamid Kassiri
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8269
Email address
kasiri-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of 1٪ lindane,1٪ permethrin and 4٪ dimeticone for the treatment of head louse infestation in female primary schools
Public title
Study of the comparative efficacy of 1٪ lindane,1٪ permethrin and 4٪ dimeticone for the treatment of head louse infestation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: female; primary school student; no lesion or redness on head; having head lice infestation Exclusion Criteria:: leaving the county; development ulcer or sensitivity
Age
From 6 years old to 10 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 444
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.558

Health conditions studied

1

Description of health condition studied
Head Louse Infestation
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis

Primary outcomes

1

Description
The rate of effectiveness
Timepoint
two, seven and fourteen days after treatment
Method of measurement
Examination

Secondary outcomes

1

Description
drug side effects
Timepoint
two, seven and fourteen days after treatment
Method of measurement
Examination

Intervention groups

1

Description
Intervantion group: Shampoo Lindane 1% (once - 5 minutes))
Category
Treatment - Drugs

2

Description
Control group: Ordinary shampoo
Category
Placebo

3

Description
Intervantion group: Shampoo Permethrin 1% (twice within a week- 10 minutes))
Category
Treatment - Drugs

4

Description
Intervantion group: Shampoo Dimethicon 4% (twice within a week- 8 hours)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Girl Schools
Full name of responsible person
Hamid Kassiri
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz jundishapur University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Nader Saki
Street address
Ahvaz jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz jundishapur University of Medical Sciences, Vice chancellor for research
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamid Kassiri
Position
Ph.D/ Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3373 8269
Fax
Email
Hamid.Kassiri@yahoo.com kasiri-h@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of medical Sciences
Full name of responsible person
Hamid Kassiri
Position
Ph.D / assistant professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3373 8269
Fax
Email
Hamid.Kassiri@yahoo.com kasiri-h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamid Kassiri
Position
Ph.D/ Assistant professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
61375-15751
Phone
+98 61 3373 8269
Fax
+91 61333738282
Email
Hamid.Kassiri@yahoo.com; Kasiri-h@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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