Double blind, randomized phase 3 efficacy trial of topical nano-liposomal Amphotericin B in the treatment of cutaneous leishmaniasis caused by L. major
Amphotericin B is an antibiotic naturally produced by Streptomyces nodosus. Amphotericin B is insoluble in water and is used as sodium deoxycholate as an emulsifying agent to maintain the suspension in Fugizone which due to side effects has a limited use. Amphotericin B is used against fungal infection and visceral leishmaniasis (VL). In line of decreasing side effects, various formulation of Amphotericin B were produced and the most effective formulation is liposomal form of Amphotericin B (AmBisome™) with a limited side effect. Ambisome injection IV, is the treatment of choice for VL in Indian continent but showed limited efficacy in the treatment of cutaneous leishmaniasis (CL). In previous studies completed by the same group, several topical formulations of liposomal form of Amphotericin B were produced. With financial support of DNDi, Geneva, Switzerland, liposomal formulation form of Amphotericin B was produced under GMP condition, in vitro including size and morphology, percent of encapsulation, stability, the rate of skin penetration, drug analysis were performed. The effect of formulation against L. tropica in vitro was assessed and Draize test was done on rabbit’s ocular and skin. In the present study the efficacy of topical formulation of amphotericin B will be checked on CL caused by L. major.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510161475N10
Registration date:2016-02-29, 1394/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-29, 1394/12/10
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
2015-10-23, 1394/08/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind, randomized phase 3 efficacy trial of topical nano-liposomal Amphotericin B in the treatment of cutaneous leishmaniasis caused by L. major
Public title
Efficacy of topical nano-liposomal Amphotericin B in the treatment of cutaneous leishmaniasis caused by L. 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; Signed informed consent voluntarily and knowingly.
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:
110
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
TUMS Ethical Committee
Street address
Keshavarz Blv
City
Tehran
Postal code
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.TUMS.REC 1304-804
2
Ethics committee
Name of ethics committee
TUMS Ethical Committee
Street address
Keshavarz Blv
City
Tehran
Postal code
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.TUMS.REC 1304-804
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 reepithelization of the lesions
Timepoint
Monthly
Method of measurement
Digital photos
Secondary outcomes
1
Description
Decrease size of the lesions
Timepoint
Monthly
Method of measurement
Digital photos
Intervention groups
1
Description
topical Nano Liposomal form of Amphotericin B twice a day for 28 days
Category
Treatment - Drugs
2
Description
Placebo ointment without liposomes or Amphotericin B
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pategah 8 Shekari
Full name of responsible person
Dr Meshkforoush
Street address
City
Esfahan
2
Recruitment center
Name of recruitment center
Payegah 8 Shekari
Full name of responsible person
Dr Meshkforoush
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Nanotechnology, Inititave concil
Full name of responsible person
Dr Saeed Sarkar
Street address
Sattar Khan Str. Habibollahi Ave, Motovalian No 9
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Nanotechnology, Inititave concil
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
CRTSDL, TUMS
Full name of responsible person
Prof Firooz
Street address
No 415, Taleghani Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CRTSDL, TUMS
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
Payegah 8th Shekari
Full name of responsible person
Dr Meshkforoush
Position
Esfahan
Other areas of specialty/work
Street address
Shahid Babaei
City
Esfahan
Postal code
Phone
+98 31 3577 5037
Fax
Email
khamesipour_ali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
CRTSDL, TUMS
Full name of responsible person
Ali Khamesipour
Position
Prof./PhD
Other areas of specialty/work
Street address
415 Taleghani Ave
City
Tehran
Postal code
Phone
+98 21 8897 0657
Fax
Email
ali.khamesipour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
CRTSDL, TUMS
Full name of responsible person
Ali Khamesipour
Position
Prof/PhD
Other areas of specialty/work
Street address
415 Taleghani Ave
City
Tehran
Postal code
Phone
+98 21 8897 0657
Fax
+98 21 8897 0658
Email
khamesipour_ali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)