Randomized, double blind, phase 3 clinical trial of efficacy and safety of radio wave-induced heat therapy plus topical liposomal Amphotericin B in comparison with heat therapy plus placebo for the treatment of zoonotic cutaneous leishmaniasis caused by Leishmania major
1) Objectives
-To evaluate the efficacy and safety of heat therapy plus topical nano-liposomal form of Amphotericin B compared with heat therapy plus placebo for the treatment of zoonotic cutaneous leishmaniasis (ZCL) caused by Leishmania major.
-To evaluate the efficacy and safety of heat therapy for the treatment of zoonotic cutaneous leishmaniasis (ZCL) caused by Leishmania major
(2)Design
A randomized double blind comparative, efficacy and safety study.
(3)setting and conduct
Male and female volunteers aged 12-60 years, with ZCL caused by Leishmania major from an endemic area of ZCL in Iran will be recruited. ZCL diagnosis will be based on parasitologically proven cases of cutaneous leishmaniasis (CL) and the species will be confirmed by PCR.
(4)Participants including major eligibility criteria
Inclusion:Males & females 12-60 years of age. Parasitological proven CL caused by L. major (identification is done by using PCR).
Exclusion:Pregnant or lactating women, Concurrent or chronic illness based on previous history, Duration of lesion more than 3 months, Number of lesions more than 5,Ulcer size greater than 3 cm in their largest diameter.
(5)Intervention
A)Heat therapy machine using current field radio frequency generator (ThermoMed™ 1.8TM, 140 Thermosurgery Technologies Inc., Phoenix, USA) already was donated by WHO to PI for another study.
B)Topical nano-liposomal Amphotericin B 0.4% (SinaAmpholeish):
(6)Outcomes
Primary outcome:Complete cure, defined as complete reepithelization of the lesion and loss of induration.
Secondary outcome:Partial cure, More than 50% reduction in size or induration compared tBatch baseline.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510031475N8
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
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
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-12-15, 1396/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, double blind, phase 3 clinical trial of efficacy and safety of radio wave-induced heat therapy plus topical liposomal Amphotericin B in comparison with heat therapy plus placebo for the treatment of zoonotic cutaneous leishmaniasis caused by Leishmania major
Public title
Efficacy of heat therapy plus topical liposomal Amphotericin B for the treatment of cutaneous leishmaniasis caused by Leishmania major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Males & females 12-60 years of age;Parasitologically proven CL caused by L. major (identification is done by using PCR); Otherwise healthy subjects on the basis of medical history; physical examination and results of blood test if requested by the physician; Ability to understand the principles of the trial and Signing an informed consent voluntarily and knowingly.
Exclusion Criteria: Pregnant or lactating women; Concurrent or chronic illness based on previous history;Duration of lesion more than 3 months;Number of lesions more than 5;Ulcer size greater than 3 cm in their largest diameter; History of full course of standard treatment (antimonials); Involvement in any other drug or vaccine trial during the study period.
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Cohort Study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethical Committee
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.Khoram St,Jomhouri Sq,Postal Code:81876-98191.Isfahan,Iran.
City
Isfahan
Postal code
81876-98191
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
495057
2
Ethics committee
Name of ethics committee
Shiraz University of Medical Sceinces, Ethic committee office
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.SUMS.REC.1395.157
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
Reepithelization of the lesions/Complete cure
Timepoint
Monthly
Method of measurement
Lesion measurement/Digital photos
Secondary outcomes
1
Description
Partial cure : Decrease size of the lesions
Timepoint
Monthly
Method of measurement
Lesion mesurement /Digital photos
Intervention groups
1
Description
Heat therapy
Category
Treatment - Devices
2
Description
Topical nano-liposomal Amphotericin B 0.4% (SinaAmpholeish) twice a day for 28 days
Category
Treatment - Drugs
3
Description
Placebo Gel without liposomes or Amphotericin B
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences,
Full name of responsible person
Dr. Fatemeh Sokhanvari
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Parasitology department, Medical School, Shiraz University of Medical Sceinces
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Parasitology department, Medical School, Shiraz University of Medical Sceinces, Zand St, Shiraz, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development (NIMAD)
Full name of responsible person
Dr. Ghaffari
Street address
No.21, Besat St., Fatemi Av., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development (NIMAD)
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
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Science
Full name of responsible person
Prof. Ali Khamesipour
Street address
No. 415, Taleghani St., Tehran Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Science
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
3
Sponsor
Name of organization / entity
Skin Diseases and Leishmaniasis Research Center (SDLRC), Isfahan University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Sokhanvari MD
Street address
Khoram St., Jomhouri Sq., Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin Diseases and Leishmaniasis Research Center (SDLRC), Isfahan University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Nano Sina CO.
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
1.Skin Disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences 2 Parasito
Full name of responsible person
1.Dr.Fatemeh Sokhanvari MD 2.Dr. Gholamreza Hatam
Position
Doctor
Other areas of specialty/work
Street address
1.Isfahan University of Medical Sciences, Khoram St, Jomhouri Sq, Isfahan, Iran. 2.Parasitology department, Medical School, Shiraz University of Medical Sceinces, Zand St, Shiraz, Iran.