comparison of therapeutic effects of administration of three different regimes for head lice treatment
Design
Randomized, controlled trial, involving 90 people in 3 parallel groups (30 patients in each group), Sealed Envelope web service was used for block randomization (www.sealedenvelope.com). Due to the fact that the patient's family must be treated in case of infestation, other family members will also be in the allocation group of the main patient.
Settings and conduct
Recruitment were done in several urban pharmacies in Tehran. Patients requesting head lice treatment after examination and confirmation of live lice (nymph or mature lice) were invited to signed the written inform consent, and if they accept the conditions, based on block randomization they were divided into three groups. Response to treatment was performed by an expert who was blinded to the groups.
Participants/Inclusion and exclusion criteria
Patients with head lice over 6 years of age who had not been treated for the infection before, were included in the study, and those with a history of allergy to topical permethrin products, pregnant women, lactating patients, and patients with a history of asthma and seizures were excluded.
Intervention groups
The first group receives permethrin shampoo that stays on the head for 10 minutes according to the instructions.
The second group receives permethrin shampoo that stays on the head for one hour according to the instructions.
The third group receives permethrin cream rinse that stays on the head for 10 minutes according to the instructions.
Main outcome variables
1) Visualization of live headlice: Examination of the scalp using the dry combing method
2) Scalp pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170608034390N8
Registration date:2021-11-14, 1400/08/23
Registration timing:retrospective
Last update:2021-11-14, 1400/08/23
Update count:0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Hadi Esmaily
Name of organization / entity
SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
esmaily_hadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of topical permethrin with three different methods for treating head lice
Public title
Evaluating three different regimes of permethrin in head lice treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with head lice infestation
Up than 6 years old
Exclusion criteria:
History of allergy or side effects with permethrin shampoo or permethrin cream
Pregnant Women
Lactating Women
History of Asthma
History of hypersensitivity reaction to permethrin
History of seizure
Active wounds in scalp
Age
From 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the block randomization method. To do this, 10 blocks of 9 people were prepared in the Sealed Envelope online software (www.sealedenvelope.com) and 30 patients were placed in each group. Due to the fact that the patient's family must be treated in case of infestation, other family members will also be in the allocation group of the main patient.
More Details: To create this list, we consider the number of block sizes as 9 and the list length as 90, in the treatment groups section, we enter three groups: Group A, Group B and Group C, in which case the software generats,10 blocks with 9 options. Out of a total of 90 codes, 30 will be Group A, 30 will be Group B, as well as 30 in Group C.
Blinding (investigator's opinion)
Single blinded
Blinding description
The expert who examines the response to the interventions and the statistical analyzer is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National ethics ommittee for biomedical research
Street address
Central Department of Ministerial of Health and Medical Education, Sima Iran St, between South Falamak and Zarafshan St, Shark Gharb
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.109
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
Presence of live lice (both adult and nymph) using the
Timepoint
First week, Second week, third week
Method of measurement
Dry combing method
Secondary outcomes
1
Description
Time to eradication
Timepoint
First week, Second week, Third week
Method of measurement
Time (Date)
Intervention groups
1
Description
Intervention group: Received permethrin shampoo that stays on the head for 10 minutes according to the instructions.
Category
Treatment - Drugs
2
Description
Intervention group: Received permethrin shampoo that stays on the head for one hour according to the instructions.
Category
Treatment - Drugs
3
Description
Intervention group: Received permethrin cream rinse that stays on the head for 10 minutes according to the instructions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Hadi Esmaily Pharmacy
Full name of responsible person
Hadi Esmaily Pharm.D.
Street address
Dr Hadi Esmaily pharmacy, Golestan St., Shahid Bagheri Town, East Hemat Highway
City
Tehran
Province
Tehran
Postal code
1495914978
Phone
+98 21 4473 1443
Email
Esmaily_hadi@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Dr Arman Sadat Mansoury Pharmacy
Full name of responsible person
Arman Sadat Mansoury Pharm.D
Street address
Dr Arman Sadat Mansoury pharmacy.7th East Alley corner.24metri Blvd.Farhang sq.saadat abad
City
Tehran
Province
Tehran
Postal code
1997756863
Phone
+98 21 2208 7244
Email
DrArman_Pharmacy@yahoo.com
3
Recruitment center
Name of recruitment center
Kokh Pharmacy
Full name of responsible person
Yashar Hatamzadeh Pharm.D
Street address
Kokh Pharmacy.Dr Qarib st.keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419893163
Phone
+98 21 6692 7610
Email
yashar.hatamzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti university of medical sciences, taleghani hospital, shahid arabi st, yemen ave, shahid chairman highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 211579064
Email
Esmaily_hadi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
esmaily_hadi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aida Edalatkhah Tatafi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
aida_alive@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the whole potential data is unpublished after being unidentifiable.
When the data will become available and for how long
start the access period 6 month after pricing the result
To whom data/document is available
researchers working in academic and industrial institutions.
Under which criteria data/document could be used
it can be used to carry out research work.
From where data/document is obtainable
Dr Hadi Esmaily, faculty of pharmacy, shahid beheshti university of medical science
What processes are involved for a request to access data/document