This study aims to evaluate efficacy of intra-lesional injection of Amphotricin B in the treatment of Antimoniate resistant or intolerant cutaneous leishmaniasis cases. Leishmaniasis patients whose clinical diagnosis has been confirmed by Gimsa stained slit skin smears and are candidate for local treatment modalities, but are unresponsive to intralesional injections of glucantim, or are unable to continue their treatments because of allergic reactions, undergo weekly intralesional injections of 1.5-2mg/dl of Amphotricin B. The standard trial is up to 12 weeks but in case of complete clinical responses the therapy will be stopped before this deadline and for therapy resistant cases it will be continued up to 6 months. Treatment result is defined as reduction in the size and induration of the leisions, and at the end of the trial will be categorized as: complete resolution (full evanescence of inflammation and indurations), Partial improvement (70-90 percent reduction in inflammation and indurations), and no response (less than 70 percent reduction in inflammation and indurations). Also, the patients will be followed up for recurrences up to a year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105223862N7
Registration date:2011-11-20, 1390/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-20, 1390/08/29
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
2008-09-01, 1387/06/11
Expected recruitment end date
2011-08-31, 1390/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intralesional amphotericin B for treatment of cutaneous leishmaniasis in patient referred to Dermatology Clinic of Imam Reza Hospital
Public title
to evaluate the efficacy of amphotericin B injection in trearment of cutaneous leishmaniasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: diagnosis of Cl based on direct skin smear or biopsy, lesion number less than 4, hypersensitivity to Antimoniate, resistance to Antimoniate therapy, informed consent signing
Exclusion criteria: hypersensitivity to amphotricin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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, Mashhad.
City
Mashhad
Postal code
Approval date
2007-06-24, 1386/04/03
Ethics committee reference number
2069
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
lesion healing
Timepoint
weekly
Method of measurement
measuring the size of induration and ulcer by caliper
Secondary outcomes
1
Description
side effect
Timepoint
weekly
Method of measurement
clinical evaluation
Intervention groups
1
Description
intralesional injection of Amphotricin, once weekly for 6-12 week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center for skin diseases and cutaneous leishmaniasis