Aims: The aim of present study is evaluation of the efficacy of fractional CO2 laser in treatment of atrophic scar of cutaneous leishmaniasis. Inclusion and Exclusion criteria: All patients more than 12 years old with atrophic scar of cutaneous leishmaniasis in hand or face are entered to study with informed satisfaction. Patients with chronic diseases like diabetes, immunodeficiency patients and individuals with skin type VI are excluded the study.
Study intervention: First the location is cleaned by isopropyl alcohol 70%, then dressing is performed for local anesthesia. After 45 minutes, the location is washed and dried. The affected site will be treated without overlap by beam size 120 micron and pals energy between 50-90 mj and densitometry between 50-100 spot/cm2. Pals energy rate will base on kind of skin and scar severity. Any cooling device will not be performed during treatment. Ice Pack is used after treatment for sedating pain and irritation. All patients will be used sunscreen cream during and after treatment. For each patient, three treatment sessions spaced one month will used.
Primary outcomes: Evaluation of patients is in start of therapy, during therapy sessions, and 3 and 6 months after the last treatment session. Evaluation will be determined by the digital photography in suitable angle and distance by determined light and camera and also based on patient satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404303862N12
Registration date:2014-07-03, 1393/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-03, 1393/04/12
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of fractional CO2 laser efficacy in treatment of atrophic scar of cutaneous leishmaniasis
Public title
Evaluation of laser efficacy in treatment of cutaneous leishmaniasis lesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 12 years old; informed consent of patient for participating in study; atrophic scar in hand or face with duration of improvement more than one year
Exclusion criteria: patients with chronic disease like diabetes and collagen vascular diseases that have a problem in scar healing; hypertrophic or keloid scars; history for receiving isotretinoin during last year; pregnancy or breastfeeding; immunodeficiency patients like patients under immunosuppressive medicines; patients who don’t complete treatment period or don’t refer for follow ups; skin type VI; history of radiotherapy in laser locations; patients with positive coiner disease like psoriasis and vitiligo
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
901024
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 healing
Timepoint
For the first before intervention, then during therapy sessions, and 3 and 6 months after the last treatment session
Method of measurement
Measuring the size of induration and scar
Secondary outcomes
1
Description
Side effects including erythema, edema, petechiae, dispigmentation and scar
Timepoint
start of therapy, 3 and 6 months after the last treatment session
Method of measurement
Physical exam
Intervention groups
1
Description
Cleansing of location by isopropyl alcohol 70%, and then dressing is performed for local anesthesia. After 45 minutes, the location is washed and dried. Treatment will be performed with laser beam size 120 micron and pals energy between 50-90 mj and densitometry between 50-100 spot/cm2 in three sessions of treatment with duration of one month.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Cutaneous leishmaniasis Research Center, Ghaem Hospital
Full name of responsible person
Dr Mahnaz Banihashemi
Street address
Ghaem hospital, Ahmad Abad street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice Chancellor for Research
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Moghimi
Position
Dermatology Resident
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahnaz banihashemi
Position
Associate professor of Dermatology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research center, Ghaem hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1801 2851
Fax
Email
banihashemim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Leishmaniasis Research Center
Full name of responsible person
Akram Momenzadeh
Position
Reserach Assistant
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)