Pilot study of efficacy of topical nano-liposomal meglumine antimoniate (Glucantime) or paromomycin in combination with systemic Glucantime for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica
Systemic or intralesional pentavalent antimonials are still the first-line treatment of Cutaneous Leishmaniasis (CL). Antimonials are not always effective especially in Anthroponotic CL (ACL), caused by Leishmania tropica, patients and resistance is reported. Therapeutic strategy with high efficacy is urgently needed especially for ACL. In this study the efficacy of liposomal formulation of Paromomycin or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Male or female aged between 12 to 60 years with active lesions will include in the study. Inclusion criteria are parasitologically proven cases of CL and a history of failure to at least one full course of systemic Glucantime. Exclusion criteria are pregnancy or lactating women and duration of lesion less than 12 months. 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 paromomycin or glucantime applied, twice daily, or placebo in the treatment of ACL in a randomized, double blind, placebo controlled clinical trial will be assessed. The patients will be followed upto 6 months after the initiation of the treatment. Complete cure equal to complete re-epithelization of all lesions will be the primary outcome of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809051475N4
Registration date:2009-11-26, 1388/09/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-11-26, 1388/09/05
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
1. Vice Chancellor of Research, Mashhad University of Medical Sciences, Mashhad, Iran
2. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2009-11-30, 1388/09/09
Expected recruitment end date
2010-07-28, 1389/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot study of efficacy of topical nano-liposomal meglumine antimoniate (Glucantime) or paromomycin in combination with systemic Glucantime for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica
Public title
Efficacy of Topical Liposomal Glucantime or Paromomycin in Combination With Systemic Glucantime for the Treatment of ACL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Male or female aged between 12 to 60 years.
2. Parasitologically proven CL due to L. tropica.
3. History of failure to at least one full course of systemic Glucantime.
4. In general good health based on history and physical examination.
5. Number of lesion at most 4.
6. Lesion size less than 3 cm.
7. Signed informed consent voluntarily and knowingly**.
** Guardian’s signature for volunteer less than 18 years old.
Exclusion criteria:
1. Pregnant or lactating women and those who are planning to be pregnant in next 60 days.
2. Use of other types of treatment for CL.
3. Involvement in any other drug or vaccine trial during the study period.
4. Known heart, kidney, liver diseases based on history and physical exam.
5. Abnormal ECG
Age
From 12 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Clinicaltrials.gov
Secondary trial Id
NCT01050777
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences
Street address
Ghorshi building, Daneshgah Ave.
City
Mashad
Postal code
Approval date
2009-11-24, 1388/09/03
Ethics committee reference number
454408
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 cure equal to Complete Re-epithelization of all lesions
Timepoint
weekly
Method of measurement
Taking digital pictures
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Systemic glucantime 60 mg/kg/day for 21 days with topical liposomal glucantime twice a day for 28 days
Category
Treatment - Drugs
2
Description
Intervention: Systemic glucantime 60 mg/kg/day for 21 days with topical liposomal paromomycine twice a day for 28 days
Category
Treatment - Drugs
3
Description
Control: Systemic glucantime 60 mg/kg/day for 21 days with topical placebo twice a day for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin disease and Cutaneous leishmaniasis research center, MUMS
Full name of responsible person
Dr Masoud Maleki
Street address
Ghaem Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical sciences
Full name of responsible person
vice-chancellor for reseach
Street address
Ghorshi building, Daneshgah Ave.
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
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran University of medical sciences
Full name of responsible person
vice-chancellor for reseach
Street address
Center for Research & Training in Skin Diseases & Leprosy,#79 Taleghani Ave, Tehran, 14166
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of medical sciences
Proportion provided by this source
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
School of pharmacy, MUMS
Full name of responsible person
Dr Mahmood reza Jaafari
Position
Professor/PhD
Other areas of specialty/work
Street address
School of pharmacy
City
Mashhad
Postal code
Phone
+98 51 1882 3255
Fax
Email
jafarimr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Research and Training in Skin Disease and Leprosy
Full name of responsible person
Dr Ali Khamesipour
Position
Associate professor/ PhD
Other areas of specialty/work
Street address
No 415 Taleghani Ave, 1416613675
City
Tehran
Postal code
Phone
+98 21 8897 0657
Fax
Email
Khamesipour_ali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of pharmacy, MUMS
Full name of responsible person
Dr Ali Badiee
Position
Assistant Professor/PhD
Other areas of specialty/work
Street address
School of pharmacy
City
Mashhad
Postal code
Phone
+98 51 1882 3255
Fax
Email
Badieea@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)