This study conducted to compare the therapeutic effects of topical liposomal Azithromycin with interalesional Meglumine Antimoniate (Glucantime) in cutaneous leishmaniasis patients referring to cutaneous leishmaniasis clinic of Ghaem Hospital. In this study 66 patients with approved cutaneous leishmaniasis will enrolled to study. The first group (26 patients) will receive topical liposomal Azithromycin with 40 mg/ml twice daily for 8 weeks. The second group will receive interalesional glucantime weekly that would be infiltrated up to a maximum dose of 2 ml or until it would be paled up to lateral margins of the lesions, for 8 weeks. The results will be evaluated on changes in the size of induration of the lesion weekly. Patient’s follow up will be done 6 months and 1 year after treatment. Response rate will determine by measuring the indurations as below: 1. complete improvement (full re-epithelialization of the lesions with or without a negative direct smear result). 2. Significant improvement: decrease in the indurations size >75%. 3. Partial improvement: decrease in the indurations size between 50%-75%. 4. Slight improvement: decrease in the indurations size between 25%-50%. 5. No improvement: decrease in the indurations size<25%.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901312082N2
Registration date:2010-04-20, 1389/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-20, 1389/01/31
Registrant information
Name
Amirali Rahsepar
Name of organization / entity
Mashad University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 1604 2497
Email address
rahseparaa841@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2009-12-24, 1388/10/03
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Topical Liposomal Azithromycin versus Intralesional Meglumine Antimoniate (Glucantime) in the Treatment of Cutaneous Leishmaniasis
Public title
Comparing efficacy of two treatment methods including topical liposomal Azithromycin versus intralesional Meglumine Antimoniate (Glucantime) in the treatment of cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: cutaneous leishmaniasis with less than 6 months duration approved by either a Giemsa direct skin smear or a positive skin biopsy of lesions, more than 3 month withdrawal from previous history of anti-leishmania therapy. Exclusion criteria: Pregnancy, breast feeding, taking any other specific treatment while participating in the study, past medical history of any systemic disease during the last 2 months, presence of known disease such as cardiac, renal or liver failure.
Age
From 2 years old to 80 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
Ehtical Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2009-12-22, 1388/10/01
Ethics committee reference number
86724
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
Every two weeks up to 8 weeks and then once again after 6 months and 1 year after completing the interventions
Method of measurement
measuring the size of lesion induration diameter with caliper
Secondary outcomes
1
Description
Side effects
Timepoint
Every two weeks till 8 weeks
Method of measurement
Base on taking history and physical examination
Intervention groups
1
Description
Treatment with multilamellar Large Vesicle (MLV) liposomes containing Azithromycin, prepared by freeze drying method, 40 mg/ml twice-daily, according to the lesion's size for 8 weeks or complete healing of the lesion.
Category
Treatment - Drugs
2
Description
Treatment with interalesional meglumine antimoniate (glucantime) injection (1-2 ml) weekly untill 8 weeks or complete healing of the leishmaniasis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Cutaneous Leishmaniasis, Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Dr Pouran Layegh, Dr Mohsen Khodami
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr Jalil Tavakoli Afshari
Street address
Central Building of Mashhad 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 sciences
Other areas of specialty/work
Street address
Research center for skin disease and cutaneous leishmaniasis, Ghaem Hospital, Ahmad abad ave
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dermatology Department, Ghaem Hospital, 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
Department of Dermatology, Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1881 4988
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center of skin disease and cutaneous leishmaniasis
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)