Objectives: The aim of this study is the comparison of Lindane1% solution versus Permethrine5% in treatment of scabies. Design: Randomized clinical trial. Setting and Conduct: We study 40 patients with Scabies referring to Tabriz Sina hospital in the form of two equal groups. Patients will randomly be assigned into two equal groups, We use Lindane 1% solution for one group and Permethrine5% cream for the other group, the treatment response will be evaluated and compared in two groups 2 and 4 weeks after the treatment. Participants including major eligibility criteria: Patients with Scabies at the age range of 2 to 80 years will be enrolled into the study . Pregnant and lactating women, patients with history of seizure of systemic diseases will be excluded. Intervention: After randomly assigning into two groups we use Lindane1% solution for one group and Permethrine5% cream for the other group. Main outcome measures (variables): Number of lesions and nocturnal itching.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081212125N1
Registration date:2013-09-14, 1392/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
Registrant information
Name
Hassan Mohammadi
Name of organization / entity
Tabriz University of Medical Sciences and Health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7774
Email address
hmohammadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Lindane1% solution versus Permethrine5% in treatment of Scabies
Public title
Scabies, comparison of Lindane1% vs. Permethrin 5%
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Scabies disease; 2-Consent for research; 3-Being at the age between 2-80 years.
Exclusion criteria: 1-Pregnant and lactating women; 2-Patients with history of seizure; 3-Patients with systemic diseases.
Age
From 2 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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
Ethics committee of Tabriz University of medical sciences and health services
Street address
Central office of Tabriz university of medical sciences, Golgasht street, Azadi street.
City
Tabriz
Postal code
5165687386
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
90105
Health conditions studied
1
Description of health condition studied
Scabies
ICD-10 code
B86
ICD-10 code description
Sarcoptic itch
Primary outcomes
1
Description
Number of Scabies skin lesions
Timepoint
2 and 4 weeks after the drug therapy
Method of measurement
With photography of lesions and their counting
Secondary outcomes
1
Description
Nocturnal itching
Timepoint
2 and 4 weeks after drug therapy
Method of measurement
Asking the patients
Intervention groups
1
Description
Intervention group: The drug therapy will be done using Permethrine5% cream.
Category
Treatment - Drugs
2
Description
Control group: The drug therapy will be done with Lindane1% solution.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina Hospital
Full name of responsible person
Dr.Farideh Golforushan
Street address
Tabriz Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Reserach, Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences and Health Services, Azadi Street, Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Reserach, Tabriz 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
Tabriz Faculty of Medicine, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farideh Golforushan
Position
Dermatologist, Associate Proffessor
Other areas of specialty/work
Street address
Dermatology ward, Tabriz Sina Hospital, Azadi street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1337 3966
Fax
Email
golforushan@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz faculty of Medicine
Full name of responsible person
Dr.Farideh Golforushan
Position
Dermatologist, Associate Professor
Other areas of specialty/work
Street address
Dermatology Ward, Tabriz Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Postal code
5154916656
Phone
+98 41 1337 3966
Fax
Email
golforushan@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Faculty of Medicine
Full name of responsible person
Dr.Ziba Mokari
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Tabriz Faculty of Medicine, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
5154916616
Phone
+98 41 1337 3966
Fax
Email
mokari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)