Comparing efficacy of combined cryotherapy and interalesional meglumine antimoniate (Glucantime) vs. cryotherapy and interalesional meglumine antimoniate alone for the treatment of cutaneous leishmaniasis
The aim of this study is comparison of three methods including combined cryotherapy and interalesional Glucantime vs. cryotherapy and interalesional Glucantime alone for treatment of cutaneous leishmaniasis. 180 patients (3 groups with 60 patients) who their cutaneous leishmaniasis will be diagnosed by direct skin smear via Giemsa method or skin biopsy and their clinical lesion course have longed below 6 months will enter to study. The first group is treated with cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding is completely indurated, and after 5 minutes interalesional Glucantime injection into the lesion, in size basis, weekly up to 8 weeks. The second group will be treated by cryotherapy 10- 20 s weekly until the lesion with 1 mm of its surrounding is completely indurated. The third group will be treated with interalesional glucantime injection into the lesion up to 8 weeks. Results will be recorded as the changes of lesion indurations in each follow up visit. Patients will be followed up 3 months after the end of treatment and lesion indurations and possible side effects will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903063862N4
Registration date:2010-05-27, 1389/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-27, 1389/03/06
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
2008-11-10, 1387/08/20
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 efficacy of combined cryotherapy and interalesional meglumine antimoniate (Glucantime) vs. cryotherapy and interalesional meglumine antimoniate alone for the treatment of cutaneous leishmaniasis
Public title
Comparing improvement efficacy of leishmaniasis patients with three treatment methods including combined cryotherapy and interalesional meglumine antimoniate (Glucantime) vs. cryotherapy and interalesional glucantime alone for the treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of cutaneous leishmaniasis less than 6 months that their disease has been approved by direct smear and stained with Giemsa or positive skin biopsy, a 3-month treatment free interval from the last treatment course. Exclusion criteria: pregnancy, lactating, receiving simultaneously any therapy during study period that has antileishmaniasis effect during 2 months ago, history of significant renal, pulmonary and cardiovascular disease.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
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 Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2007-05-26, 1386/03/05
Ethics committee reference number
86721
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 time 6th and 8th weeks after treatment and for the second time in follow up visit after 3 months of beginning 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 cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding is completely infiltrated, and after 5 minutes, interalesional Glucantime injection into lesion, in size basis, weekly up to 8 weeks
Category
Treatment - Other
2
Description
Treatment with cryotherapy 10-20 s, until the lesion and 1 mm of its surrounding is completely infiltrated, weekly up to 8 weeks
Category
Treatment - Other
3
Description
Interalesional Gluantime injection into lesion, in size basis, until the lesion is completely infiltrated and indurated, weekly up to 8 weeks
Category
Treatment - Drugs
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 fateme Shirzad
Street address
Ahmad Abad Street, Ghaem Hospital
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, Dr Jalil Tavakol Afshari
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 leishmaniasis, Office building, Ghaem Hospital, Ahmad Abad Street
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
Dermatology Department, 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)