The aim of this study is evaluation of topical liposomal azithromycin for treatment of acute cutaneous leishmaniasis.Considering inclusion and exclusion criteria, patients will be divided to control and interventional groups and visit every week till 6 weeks for assessing treatment response based on change in induration size (measuring with collis) and erythema. Then improvement response classified to 3 grade a) mild: decrease in induration and erythma < 30% b) moderate:decrease in induration and erythma between 30-60% c)significant: decrease in induration and erythma >60% or getting negative skin smear test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031216955N1
Registration date:2014-05-16, 1393/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Pouran Layegh
Name of organization / entity
department of dermatology, Ghaem hospital, Mashhad, Iran
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2861
Email address
momenzadeha1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-10-01, 1388/07/09
Expected recruitment end date
2011-10-01, 1390/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical liposomal azithromycin for treatment of acute cutaneous leishmaniasis
Public title
Topical treatment of cutaneous leishmaniasis with lipozomal azithromycin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of cutaneous leishmaniasis with less than 12 weeks of clinical course; Not receive any treatment before
Exclusion criteria: Pregnancy; Lactating; Receiving simultanous treatment with other methods during treatment course; Sensitivity or intolerance to Macrolids;
History of significance renal; Pulmonary and cardiovascular disease
Age
From 1 year old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2008-07-23, 1387/05/02
Ethics committee reference number
2159
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 improvement
Timepoint
Weekly until 6 weeks
Method of measurement
Measuring the size of induration and ulcer by caliper
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: use of topical liposomal Azithromycin twice daily for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: injection of intralesional meglumine antimoniate (glucantime) weekly for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cutaneous Leishmaniasis Clinic,Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice Chancellor for Research
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
Cutaneous Leishmaniasis Research center, Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran layegh
Position
Associate professor of dermatology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research center, Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1801 2851
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate professor of Dermatology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research center, Ghaem hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1801 2851
Fax
Email
layeghpo@mums.ac.ir, src@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Momenzadeh
Position
Bachelor of Biology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
Fax
Email
src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)