The aim of this clinical trial is to assess the efficacy of topical nano-liposomal 10 % paromomycin (Lip-PM) in the treatment of cutaneous leishmaniasis (CL) caused by L. major compared with placebo. Inclusion criteria are parasitologically proven cases of CL based on positive smear and/or culture, age 12-60 years, duration of lesion less than 3 months, number of lesions at most 5, lesion size not more than 30 mm in one direction, be volunteer to participate and sign informed consent, exclusion criteria are pregnant or lactating women and duration of lesion more than 3 months, participation in any other trial in last 6 months. A total of 144 ZCL patients will be recruited and double blind randomly assigned in 2 arms, 72 patients in each arm. The patients will be double blind randomly receiving either topical Lip-PM or placebo twice daily for 4 weeks (28 days), the study will be completed according to GCP (Good Clinical Practice) guide lines. The patients will be visited at week 4, 8 and at 3 and 6 months after initiation of treatment. At each visit the lesions’ characteristics such as size of induration, ulcer and scar will be recorded. The data will be compared between the patients who received the treatment (Lip-PM) wand the group who received placebo. The follow up of the patients is for 6 months after beginning of the treatment. The primary clinical efficacy parameter is complete re-epithelization of all lesions with disappearance of induration (with or without scar).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108301475N6
Registration date:2011-10-05, 1390/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-05, 1390/07/13
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
Zoonoses control Center for diseases control Ministry of Health and..; Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences; Nanotechnology Research Center Mashhad University of Medical Sciences
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-03-01, 1390/12/11
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 paromomycin in the treatment of cutaneous leishmaniasis caused by L. major
Public title
Double blind, randomized phase 3 efficacy trial of topical nano-liposomal paromomycin in the treatment of cutaneous leishmaniasis caused by L. major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age 12-60 years; Cutaneous leishmaniasis (CL) lesion induced by L. major; Parasitological proven cases of CL by direct smear, culture or PCR; Healthy individual otherwise of CL; onset less than 3 months; number of lesion 5 at most; ulcer size not more than 30 mm in one size; willing to participate and sign informed consent. Exclusion criteria: pregnant or lactating women; duration of lesion more than 3 months; serious illness such as heart kidney or liver diseases based on physical exam and laboratory tests; CL lesion resistant to treatment or recidivans form of lesion; number of lesions more than 5; ulcer size more than 30 mm in one direction participation in any other clinical trial in last 6 months.
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:
144
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
University Ethical Committee, Center for Research and Training in Skin Diseases and Leprosy, Tehran
Street address
415 Taleghani Avenue
City
Tehran
Postal code
1416613675
Approval date
2011-05-14, 1390/02/24
Ethics committee reference number
J/423/201
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis otherwise Healthy
ICD-10 code
B55.1
ICD-10 code description
minor skin disease
Primary outcomes
1
Description
Complete cure
Timepoint
at weeks 4 and 8 and at months 3 and 6
Method of measurement
Measurement of reepithelization
Secondary outcomes
1
Description
Partial cure
Timepoint
at weeks 4 and 8 and at months 3 and 6
Method of measurement
Measurement of reepithelization
Intervention groups
1
Description
Treatment with topical Nano liposomal form of 10% paromomycin, twice a day for 28 days
Category
Treatment - Drugs
2
Description
Placebo topically is used twice a day for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr Fariba Farid
Street address
Isfahan University of Medical Sciences, Vice Chancellor for Health
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Center for Research & Training in Skin Diseases & Leprosy Tehran University of Medical Sciences; Dis
Full name of responsible person
Dr Alireza Firooz, Dr Gooya or Shirzadi, Dr Jaafari
Street address
415 Taleghani Avenue, Hafez Avanue, BooAli Sq
City
Tehran, Tehran, Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Research & Training in Skin Diseases & Leprosy Tehran University of Medical Sciences; Dis
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
Dr Ali Khamesipour
Position
Prof/PhD
Other areas of specialty/work
Street address
415 Taleghani Avenue
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Fax
+98 21 8897 0658
Email
khamesipour@tuma.ac.ir
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
Dr Ali Khamesipour
Position
Prof/PhD
Other areas of specialty/work
Street address
415 Taleghani Avenue
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Fax
+98 21 8897 0658
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
Prof/PhD
Other areas of specialty/work
Street address
415 Taleghani Avenue
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Fax
+98 21 8897 0658
Email
khamesipour@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)