Clinical trial for the Comparison of the effect of PDL laser and injection of glucantime in the treatment of cutaneous lesions of leshmaniasis patients
The goal of this study is to evaluate the effect of PDL laser versus the routine treatment with intralesional glucantime injection. Inclusion criteria is having at least 2 cutaneous lesion with positive smear.The patients who have been treated with any other method will be excluded from study.
This is a not blind not randomized randomised clinical trial. The simple suze is 19 patients with 38 cutaneous lesions.Each if the lesions will be treated with one of the two treatments.
For one of the lesions, glucantime (vial 1gr/5cc) will be injected intralesional with insulin syringe. The interval between the injections will be one week until the lesion will be completely cured and maximum 10 injections will be done. The other lesion will be treated with PDL laser(N light, model A00-0159) with the setting of 7j/cm2 fluence, and 5cm spot size. Laser therapy will be continued with 2 weeks interval, until complete cure of the lesion or maximum 4 sessions. The lesions will be assessed through photography and induration score (from 1 to 5) at the begining and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072018536N1
Registration date:2017-03-21, 1396/01/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Ehsan Omidian
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 626 8737
Email address
omidian.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial for the Comparison of the effect of PDL laser and injection of glucantime in the treatment of cutaneous lesions of leshmaniasis patients
Public title
Evaluation of PDL laser for the treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 5-55 years; having at least 2 leishmania lesion on the everywhere of body skin with positive direct smear for leishman body.
Exclusion criteria: Pregnancy; lactation; using any other treatments before the beginning of the study.
Age
From 5 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapur University of Medical Sciences
Street address
Daneshgah sq, Ahvaz, Iran
City
Ahvaz
Postal code
15794-61357
Approval date
2014-04-23, 1393/02/03
Ethics committee reference number
Ajumsrec.1393.15
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
Induration index
Timepoint
Before the begionning of the study, Every 2 weeks for 10 weeks.
Method of measurement
Physical examination by dermatologist
Secondary outcomes
1
Description
Post inflammatory hyperpigmantation
Timepoint
Every 2 weeks for 10 weeks.
Method of measurement
Physical examination by dermatologist
Intervention groups
1
Description
Intervention group 1: For one of the lesions, glucantime (vial 1gr/5cc) will be injected intralesional with insulin syringe. The interval between the injections will be one week until the lesion will be completely cured and maximum 10 injections will be done.
Category
Treatment - Drugs
2
Description
Intervention group 2: The other lesion will be treated with PDL laser(N light, model A00-0159) with the setting of 7j/cm2 fluence, and 5cm spot size. Laser therapy will be continued with 2 weeks interval, until complete cure of the lesion or maximum 4 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Ehsan Omidian
Street address
Imam Khomeini hospital, Azadegan Blvd
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Radmanesh clinic
Full name of responsible person
Seyed Mohammad Radmanesh
Street address
Eastern 6 street, Kianpars, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr Radmanesh clinic
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
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Ehsan Omidian
Position
Dermatology resident
Other areas of specialty/work
Street address
Imam khomeini hospital, Azadegan st, Ahvaz
City
Ahvaz
Postal code
Phone
+98 33302058
Fax
Email
Omidian.e@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz jondishapour university
Full name of responsible person
Seyed Mohammad Radmanesh
Position
Dermatologist
Other areas of specialty/work
Street address
Imam khomeini hospital, Azadegan st, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 2054
Fax
Email
radmanesh.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Ehsan Omidian
Position
Dermatology resident
Other areas of specialty/work
Street address
Imam khomeini hospital, Azadegan st, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3336 2054
Fax
Email
omidian.e@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)