Determination of the Effectiveness of Dimethicone Lotion in Comparison with Shampoo Permethrin 1% in the Treatment of Head Lice in Clients to Health Care Centers in Ardabil City in 2017.
Design
A controlled, parallel-group, open-label, randomized, phase 3 clinical trial with 100 patients. Randomization is carried out using an online table of random numbers.
Settings and conduct
In this study, 5 health centers will be randomly chosen from those serviced by Ardabil City's health center, and patients will be thoroughly examined for two months with informed consent.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Having a health record in the health centers of Ardabil city
2. People with head lice based on the observation of nit or lice
3. Informed consent to the study.
Exclusion criteria:
1. Pregnant people
2. People who are breastfeeding
3. People who have chronic scalp disease
4. People who have used anti-lice products or hair dyes and hair curlers in the last 2 weeks.
5. People who have used any type of treatment to get rid of lice in the last month.
6. People who have had a history of taking antibiotics in the last two weeks
Intervention groups
People with head lice
In the intervention group, the lotion was used, and instruction on how to use it properly was given by the research team in training sessions according to the national guidelines.
In the control group, the shampoo was used, and instruction on how to use it properly was given by the research team in training sessions according to the national guidelines.
Main outcome variables
According to the volume, length, and type of hair as well as the severity of the infestation, the success rate of treatment with lotion and shampoo for head lice sufferers will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041895N1
Registration date:2023-08-23, 1402/06/01
Registration timing:retrospective
Last update:2023-08-23, 1402/06/01
Update count:0
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
Eslam Moradi-Asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 3775
Email address
moradiasl83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Dimeticone Lotion and 1% Permethrin Shampoo for the Treatment of Head Lice in Clients to Health Centers
Public title
Effect of Dimethicone and Permethrin in the treatment of head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a file in health centers in Ardabil city
Lice sufferers based on the observation of nit or lice
The informed consent of the individual to study
Exclusion criteria:
Individuals who are pregnant and breastfeeding
Individuals with chronic scalp disease
Individuals who have used anti-lice products or hair dyes and hair curlers in the last 2 weeks.
Individuals who have used any type of treatment to get rid of lice in the last month.
Individuals who have taken antibiotics in the last two weeks
Age
From 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
1
One person is chosen for shampoo treatment and one for lotion treatment.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization list was generated using the website https://www.sealedenvelope.com/simple-randomiser/v1/. This list contained 50 A codes and 50 B codes. This list was only available to the randomization supervisor in the form of A and B codes. When the patient went to the health center to receive head lice services, he/she received the assigned code by phone from the supervisor. After this stage, the research team provided services to the patients based on the received code.
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
Ethics committee of Ardabil University of Medical Sciences
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
5618953141
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.ARUMS.REC.1397.170
Health conditions studied
1
Description of health condition studied
Pediculosis
ICD-10 code
B85
ICD-10 code description
Pediculosis and phthiriasis
Primary outcomes
1
Description
hair type, volume, and length, as well as intensity of infestation
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dimethicone lotion 4% (Sepidaj company) was used, and training on how to use it correctly was provided by the research team specifically and in training classes (2 sessions and 1 hour each session) according to national guidelines.
Category
Treatment - Drugs
2
Description
Control group: Permethrin 1% shampoo (Gilaranco company) was used, and training on how to use it correctly was provided by the research team specifically and in training classes (2 sessions and 1 hour each session) according to national guidelines.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Health Center
Full name of responsible person
Eslam Moradi-Asl
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 3784
Fax
+98 45 3353 4786
Email
moradiasl83@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahab Behlouli
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4776
Fax
+98 45 3353 4757
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Eslam Moradiasl
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 3775
Fax
Email
moradiasl83@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Eslam Moradiasl
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 3775
Fax
+98 45 3353 2004
Email
moradiasl83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Eslam Moradiasl
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 3775
Fax
+98 45 3353 2004
Email
moradiasl83@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
Yes - There is 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
Data that is unrecognizable and public will be expressed as a percentage.
When the data will become available and for how long
It will be published after the study is completed and written.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
To use the results of this study to prevent disease, it will be published without identifying the participants.
From where data/document is obtainable
Dr. Eslam Moradi-Asl, Health Faculty, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil City. Email: Moradiasl83@yahoo.com
Tel: +98 9143546796
What processes are involved for a request to access data/document
Written Request and Consent of Deputy Research and Technology.