In this clinical trial study, 80 patients with Scabies, who were attended in the dermatology out patient department of Sina Hospital of tabriz medical science, were examined, and efficacy of oral Ivermectin and topical Lindane lotion for treatmet of Scabies, was compared. All patients were divided into two groups randomly.The key inclusion criteria:(nocturnal pruritus; burrow or/and typical scabietic lesion),and the key exclusion criteria:(under 2 years old; pregnancy;positive history of seizure or epiepsy; history of immunodeficiency diseases; history of anti scabies drug usage in last month.) The first group received single dose of 200 μg/kg body weight oral Ivermectin and the other group received topical Lindane lotion 1% .In the case of treatment failure at two week follow up, treatment was repeated. Treatment was evaluated at intervals of 2 and 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205249844N1
Registration date:2014-07-13, 1393/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-13, 1393/04/22
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-04-04, 1392/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative trial of oral Ivermectin vs. Topical Lindane lotion 1% in the treatment of Scabies
Public title
Efficacy of oral Ivermectin for treatment of Scabies
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: (Under 2years old; Pregnancy ; Positive history of seizure or epilepsy ; Positive history of immunodeficiency diseases; History of anti scabies drug usage in last month . ) Inclusion criteria: (Nocturnal pruritus; Burrow or/and typical scabietic lesion on the classical sites; History of similar symptoms in their families . )
Age
From 2 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
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
Ethic committee of Tabriz University of Medical Sciences.
Street address
Gol Central Building of Tabriz University of Medical Sciences,Glgasht Ave,Tabriz
City
Tabriz
Postal code
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
9296
Health conditions studied
1
Description of health condition studied
Scabies
ICD-10 code
XII
ICD-10 code description
Scabies,sarcoptic itch
Primary outcomes
1
Description
Response to the treatment of the old lesion and absence of new lesion
Timepoint
2, 4 weeks after treatment
Method of measurement
Physical examination and comparing old lesion picture with the site of lesion after medical treatment
Secondary outcomes
1
Description
Absence of pruritus of lesion
Timepoint
2, 4 weeks after the treatment
Method of measurement
physical examination
Intervention groups
1
Description
Group A recieved single dose of 200 mic/kg oral ivermectin, repeat other dose at second week after treatment.
Category
Treatment - Drugs
2
Description
Group B recieved 30 ml, topical lindane lotion 1% , on all body surface at night and removed 8 to 12 hours later.Repeat other dose at second week after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Department of Sina Hospital, Tabriz University of Medical Sciences.
Full name of responsible person
Elnaz Poorhasani
Street address
Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square.
Full name of responsible person
Dr Mehdi Amirnia
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Central Building of Medical Sciences, Daneshgah Square.
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 research, Tabriz University of Medical Sciences, Daneshgah Square.
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
Daneshgah Square, Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Poorhasani
Position
MD
Other areas of specialty/work
Street address
Dermatology Department, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
Email
el.poorhasani@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dermatology Department, Sina Hospital, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Mehdi Amirnia
Position
Dermatlogist
Other areas of specialty/work
Street address
Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
Email
el.poorhasani@gmail
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dermatology Department, Sina Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Poorhasani
Position
MD
Other areas of specialty/work
Street address
Dermatology Department, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 1541 2101
Fax
Email
el.poorhasani@gmail
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)