The scabies is a current dermal disease which included many peoples around the world and in Iran. The insect cause several signs like irritation, inflammation, severe itching and .... in patients. Several drugs such as permethrin and lindane have been used for treatment, but there are several reports for resistance to these preparations. There is no official dosage form of malathion in Iran. The malathion lotion formulated in drug stores as compounding drug specially by using ethanol as cosolvent. This solvent have some irritative effect on skin. In this researsh the ethanol free lotion of malathion (0.5%) will be prepared and its effect on scabies in comparison with permethrin cream 5% will be evaluated.
Patients will diagnosed by dermatologist and samples patients who received anti scabies during last 3 months; skin damage in lesions; sensitivity against preparation will be excluded from study. 60 patients (30 in every group) were received malathion lotion and permetrine cream respectively. The patients will be received lotion topically once a day for 2 weeks. The lesion count and other symptoms will be evaluated for 4 weeks.
General information
Acronym
Effect of malation lotion on scabies
IRCT registration information
IRCT registration number:IRCT2014110110203N5
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Majid Saeedi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3082
Email address
msaeedi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ethanol free lotion of malathion (0.5%) on scabies in comparison with permethrin cream 5%
Public title
Effect of Malation lotion on scabies in comparison with permethrin cream 5%
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The pationts which diagnosed by dermatologist;
Exclusion criteria: Pregnancy; lactation; fever; antibiotic therapy; patients who received anti scabies during last 3 months; skin damage in lesions; sensitivity against preparation;
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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, Chancellor of Research, Mazandaran University of Medical Sciences
Street address
Moallem sq.
City
Sari
Postal code
Approval date
2014-02-01, 1392/11/12
Ethics committee reference number
92-88
Health conditions studied
1
Description of health condition studied
Scabies
ICD-10 code
B86
ICD-10 code description
B86 scabies
Primary outcomes
1
Description
skin lesion
Timepoint
time zero, 2 week, 4 week
Method of measurement
observation
Secondary outcomes
1
Description
Lesion site
Timepoint
time zero, 2 week, 4 week
Method of measurement
observation
Intervention groups
1
Description
case: Malathion lotion 0.5%, one time per day (without cleaning) for 2 weeks
Category
Treatment - Drugs
2
Description
control: Permetrin cream 5% , one time per day (without cleaning) for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic
Full name of responsible person
Majid Saeedi
Street address
Boo-Ali Hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Ahmad Ali Enayati
Street address
Moallem sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Faculty of Pharmacy
Full name of responsible person
Majid Saeedi
Position
Professor
Other areas of specialty/work
Street address
18th. km. of Khazar Road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Majid Saeedi
Position
Ph.D.
Other areas of specialty/work
Street address
18th. km. of Khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Majid Saeedi
Position
Professor
Other areas of specialty/work
Street address
18th. km. of Khazar road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
majsaeedi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)