This study, which is performed as clinical experimentation, is regarding Leishmaniasis. The samples were selected from among the leishmaniasis patients who visited the 17 Shahrivar Hygiene and Treatment Center in Ahwaz.
In the first session, two separate leishmanial injuries are specified on the patient's body. The two injuries are subjected to clinical examination. The rate of induration was determined and a score of 1 to 5 was assigned by the examiner (a dermatology assistant). Then each injury was treated using one of the following two methods:
A: To one of the injuries, Meglumine antimony is injected using a 1 cc insulin syringe. The maximum injection amount in each session is 1-2 cc. The injection is repeated weekly until the complete improvement of the injury, with a maximum of 10 injections.
B: The other injury is subjected to laser treatments (AlexandritLtroni, Nd-YAG, and flow index of 220 J).
Treatment with Nd-YAG is repeated in 2-week intervals until complete improvement (no indurations). (Maximum 5 treatment sessions.)
In every treatment session, each injury is photographed and the rate of in duration is assigned a score of 1 to 5 by the examiner. After 10 weeks from the start of the treatment, the treatments are stopped and the above information is registered again. Follow-up of the skin injuries is performed after improvement and 3 months later. In each follow-up session, the injury is examined with regards to the scar and PIH, and photographed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042911363N2
Registration date:2017-06-09, 1396/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Hannaneh Davoodzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
davoodzadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between the Effect of Nd: YAG Laser and Glucantime on Treatment of Cutaneous Leishmaniasis
Public title
Comparison Between the Effect of Nd: YAG Laser and Glucantime on Treatment of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Being 5 to 55 years of age; having at least two leishmanial injuries (leishmaniasis is defined as having a clinical injury according to Cutaneous leishmaniasis along with positive smear test regarding leishmanial body confirmed by a pathologist.
Exclusion criteria:Being pregnant or nursing; receiving any prior treatments (including medical or cryotherapy or laser or other destructive methods).
Age
From 5 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.540
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 improvement of the injury
Timepoint
At the end of every session, 10 weeks after start of treatment, and 3 months after improvement
Method of measurement
Measuring the induration and the size of the injury
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 2: The other injury is subjected to laser treatments (AlexandritLtroni, Nd-YAG, and flow index of 220 J).
Category
Treatment - Other
2
Description
Intervention group 2: To one of the injuries, Meglumine antimony is injected using a 1 cc insulin syringe. The maximum injection amount in each session is 1-2 cc. The injection is repeated weekly until the complete improvement of the injury, with a maximum of 10 injections.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz 17th Shahrivar Center
Full name of responsible person
Mohammad Omidian
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saaki Naader
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
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 Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Jad Babai
Position
Dermatologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+61 35874366
Fax
Email
samsorena@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Omidian
Position
Dermatologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+61 35874366
Fax
Email
momedian@yaho.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Maryam Jad Babai
Position
Dermatologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+61 35874366
Fax
Email
samsorena@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)