The aim of this study is comparing efficacy of two treatment methods including oral azithromycin and cryotherapy in children with cutaneous leishmaniasis caused by leishmania tropica. Sixty six patients below 14 years old (two groups with 33 individuals) that their cutaneous leishmaniasis have been diagnosed by direct skin smear (Giemsa staining method) or skin biopsy and their clinical lesion have longed less than 6 months will enter to study. The first group will be treated with oral azithromycin 10-12mg/kg daily up to 10 days in first session and then it will be repeated during 3 following periods. The second group will be treated with cryotherapy 10-20 s weekly, until the lesion with 1 mm of its surrounding are completely infiltrated. The result will be recorded as changes of lesion indurations basis in each follow up visit. Patients will be followed for 3 months after finishing treatment and lesion indurations and possible side effects will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903023862N3
Registration date:2010-05-23, 1389/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-23, 1389/03/02
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2007-08-21, 1386/05/30
Expected recruitment end date
2010-07-21, 1389/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing evaluation of oral Azithromycin and cryotherapy in cutaneous leishmaniasis in children
Public title
Comparing two methods of oral Azithromycin and cryotherapy in cutaneous leishmaniasis treatment in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of cutaneous leishmaniasis with less than 6 months of clinical course that their disease have been approved by direct smear and stained with giemsa method or skin biopsy, age<14, a 3-month treatment free interval from the last treatment course. Exclusion criteria: pregnancy, lactating, receiving simultaneously any therapy that has antileishmaniasis effect during 2 months ago, history of significance renal, pulmonary and cardiovascular disease, sensitive to azithromycin.
Age
From 1 year old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2007-06-10, 1386/03/20
Ethics committee reference number
6250
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Complete healing
Timepoint
For the first intervention, at the end of each month until 4 months and for second intervention at the end of 8th week and during follow up of patients in both studied group after 3 months of beginning of the study
Method of measurement
Measuring the size of induration and ulcer
Secondary outcomes
1
Description
Side effects
Timepoint
At each follow up visit
Method of measurement
physical exam
Intervention groups
1
Description
Treatment with oral azithromycin 10-12 mg/kg daily untill 10 days and then repeat during 3 consecutive periods according to the improvement basis
Category
Treatment - Drugs
2
Description
Treatment with cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding become fully infiltrated, weekly up to 8 weeks based on lesion size or complete lesion improvement
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center of Skin Disease and Cutaneous leishmaniasis, Ghaem Hospital
Full name of responsible person
Dr Mahnaz Banihashemi, Dr Shagufta Nargis
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Scinences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and cutaneous leishmaniasis, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir , hadis_yousefzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology,Ghaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Mahnaz Banihashemi
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology,Ghaem Hospital, Mashad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
banihashemim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center for skin disease and cutaneous leihmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and leishmaniasis, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir , hadis_yousefzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)