The prevalence of hypertrophic Scars following the burns is high (about 70%) And it still is one of the therapeutic challenge. Various treatments with different mechanisms have been suggested. one of the new and effective present treatments is using CO2 laser. Recently the role of Rampamycin ,collagen expression regulator, in hypertrophic scars treatment has been proposed and also this drug probably could affect dermal fibroblasts expression by inhibiting vascular endothelial growth factor.the aim of this study is to evaluate the effectiveness rate of fractional laser, Rapamycin topical cream and combination of both ways of laser and cream for burns scar treatment. in this clinical trial study 60 burning patients including men and women ,age range of 8-60 y/o,will be entered for pilot and they will be randomized by table of random numbers to three groups of 20 patients for treating by; only laser, only 1% Rapamycin local cream and combination of both ways.the inclusion criteria will be all of the patients with hypertrophic burning scar who refer to dermatology clinic of hazrate rasool hospital. Patients that suffer from psychological disorders whom unable to fill the concurrence paper, and pregnant or breast feeding ladies will be excluded from the study. blinding is impossible because of obvious intervention. Laser therapy will be done in three sessions with four weeks interval and Rapamycin cream will be added on lesions after each session. It will be recommended that to continue using the cream twice a day for 12 weeks. all the patients will be photographed by Visioface Before starting treatment, in each session and 6 months after the treatment thus scar improving rate and also probably adverse effects will be evaluated by associated objective and subjective factors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052318210N7
Registration date:2017-09-10, 1396/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
iran university of medical science
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of burn scars using Ablative CO2 fractional Laser and topical rapamycin (sirolimus)
Public title
Treatment of burn scars using Ablative CO2 fractional Laser and topical rapamycin (sirolimus)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : All of patients with burn hypertrophic scar who will come to RasoulAkram hospital.
Exclusion criteria: 1. do not fill the consent inform 2. pregnancy or breast feeding women 3. psychological disorders that could not understand or fill consent inform
Age
From 8 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
60 patients(men and women) will divide by computer table of random numbers to three (equal 20 patients in each) groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Iran University of Medical Sciences
Street address
Hemat Highway
City
Tehran
Postal code
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.IUMS.REC 1395.95-04-204-30038
Health conditions studied
1
Description of health condition studied
Burn NOS
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
Primary outcomes
1
Description
contracture
Timepoint
every months in treatment period and 6 months after treatment completion
Method of measurement
Imaging of skin and scoring with Vancouver scar scale
2
Description
texture
Timepoint
every months in treatment period and 6 months after treatment completion
Method of measurement
Imaging of skin and scoring with Vancouver scar scale
Secondary outcomes
1
Description
satisfaction
Timepoint
every months in treatment period and 6 months after treatment completion
Method of measurement
Interview
2
Description
Skin colour
Timepoint
every months in treatment period and 6 months after treatment completion
Method of measurement
Imaging of skin and scoring with Vancouver scar scale
3
Description
Atrophy
Timepoint
every months in treatment period and 6 months after treatment completion
Method of measurement
Imaging of skin and scoring with Vancouver scar scale
Intervention groups
1
Description
Intervention in first group is CO2 Fractional laser, on burn scars. Device will set with skin types of patients, anatomic place and scars color and depth. laser will applied in three sections monthly.
Category
Treatment - Devices
2
Description
Intervention in second group is Rapamycin Cream. patients will treat with Rapamycin 1% Cream for 12 weeks.
Category
Treatment - Drugs
3
Description
Intervention in third group is combination therapy of CO2 Fractional laser(on burn scars that will applied in three sections monthly) added with Rapamayci 1% Cream.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Vice Chancellor for Research, Seyed Ali Javad Moosavi
Street address
Office of the Chancellor for Research, Iran University of Medical Sciences, Crossroad of Shahid Hemmat and Shahid Chamran Express Ways, Tehran, Islamic Republic of Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
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
Iran University of Medical Science
Full name of responsible person
Elham Behrangi
Position
Associate Professor
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St, Satarkhan St, Tehran, Iran. Tel :0098 2166517341-9
City
Tehran
Postal code
Phone
+98 21 6650 2040
Fax
Email
Elham.Behrangi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Elham Behrangi
Position
Associate Professor
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran. Tel :+98 (21) 66517341-9
City
tehran
Postal code
Phone
+98 21 6650 2040
Fax
Email
Elham.Behrangi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Mohammadreza Ghassemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran. Tel :+98 (21) 66517341-9
City
Tehran
Postal code
Phone
+98 21 6650 2040
Fax
Email
Mohammadreza.Ghassemi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)