Double blind, randomized clinical trial on efficacy of combination of meglumine antimoniate (Glucantime) and topical nano-liposomal paromomycin for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica
Pentavalent antimonials, which are still the WHO first-line treatment for Cutaneous Leishmaniasis (CL), requires multiple injections and are painful; as such, not tolerated by most of the patients resulted in low compliance, moreover antimonials are not always effective especially in Anthroponotic CL (ACL) patients. In addition, resistance to pentavalent antimonials has been reported. In this study the efficacy of 3 weeks treatment with intramuscular injections of 60 mg/kg/day Glucantime in combination with 4 weeks treatment with topical nano-liposomal 10 % paromomycin (Lip-PM) applied, twice daily, or placebo in the treatment of ACL in a randomized, double blind, placebo controlled clinical trial according to GCP (Good Clinical Practice) guide lines will be assessed. In the proper formulations and at the appropriate sizes, liposomes deliver drugs to the skin on the basis of the similarity of the bilayer structure of the lipid vesicles to that of the natural membrane and target the macrophages within the dermis. Inclusion criteria are parasitologically proven cases of CL based on positive smear and/or culture and age 12-60 years and exclusion criteria are pregnant or lactating women and duration of lesion more than 6 months. A total of 120 patients will be recruited and randomly assigned in 2 groups. The patient will follow upto 6 months after beginning of the treatment. The primary clinical efficacy parameter will be the complete re-epithelization of all lesions with disappearance of induration (with or without scar).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904241475N5
Registration date:2015-09-21, 1394/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-21, 1394/06/30
Registrant information
Name
Ali Khamesipour
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 0657
Email address
khamesipour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-10-07, 1390/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind, randomized clinical trial on efficacy of combination of meglumine antimoniate (Glucantime) and topical nano-liposomal paromomycin for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica
Public title
Double blind, randomized clinical trial on efficacy of combination of Glucantime and topical paromomycin for the treatment of cutaneous leishmaniasis caused by Leishmania tropica
Purpose
Treatment
Inclusion/Exclusion criteria
I) Inclusion criteria:a) Parasitologically proven cases* of CL based on positive smear and/or culture; b) Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician); c) Age 12-60 years; d) Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
* Direct smear, culture and PCR will be done on every sample to identify the causative agent.
II) Exclusion criteria: a) Pregnant or lactating women; b) Duration of lesion more than 6 months; c) Number of lesions more than 4; d) Ulcer size greater than 3 cm in their largest diameter; e) History of full course of standard treatment (antimonials); f) History of allergy to Glucantime; g) Serious systemic illnesses (as judged by the physician); h) Participation in any drug trials in the last 60 days.
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethical Committee on Biomedical Research
Street address
Ministry of Health
City
Tehran
Postal code
Approval date
2010-07-31, 1389/05/09
Ethics committee reference number
1K89P/28
Health conditions studied
1
Description of health condition studied
Protozoal diseases
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
complete re-epithelization of all lesions with disappearance of induration
Timepoint
weekly
Method of measurement
Digital pictures
Secondary outcomes
1
Description
Reduction in the size of ulcer and induration.
Timepoint
weekly
Method of measurement
Digital pictures
Intervention groups
1
Description
Control:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical placebo twice daily for 28 days
Category
Placebo
2
Description
Intervention:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical Lip-PM twice a day for 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Ali Khamesipour
Street address
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)
Full name of responsible person
Ali Khamesipour
Street address
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)
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
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Full name of responsible person
Ali Khamesipour
Position
Associate Prof.
Other areas of specialty/work
Street address
Center for Research and Training in Skin Diseases and Leprosy, P.O.Box 14155-6383
City
Tehran
Postal code
14155-6383
Phone
+98 21 8897 0657
Fax
Email
Khamesipour_ali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Full name of responsible person
Ali Khamesipour
Position
Associate Prof.
Other areas of specialty/work
Street address
Center for Research and Training in Skin Diseases and Leprosy, P.O.Box 14155-6383
City
Tehran
Postal code
14155-6383
Phone
+98 21 8897 0657
Fax
Email
Khamesipour_ali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Full name of responsible person
Ali Khamesipour
Position
Associate Prof.
Other areas of specialty/work
Street address
Center for Research and Training in Skin Diseases and Leprosy, P.O.Box 14155-6383
City
Tehran
Postal code
14155-6383
Phone
+98 21 8897 0657
Fax
Email
Khamesipour_ali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)