The purpose of this study is Comparing the effect of Red light LED ( 625 nm Wavelength) with white light LED on post- co2 laser wound healing. Inclusion criteria: age over 15 years of age and under the age of 65; any patient that received equal fractional CO2 laser on both sides of face that due to acne scarring or rejuvenation; signature consent form; Exclusion criteria: age below 15 years and over 65 years; co2 laser with different parameters; wounds are not very standard and good for study; on both sides of face the energies and the number of laser passes are not the same and the wounds on both sides of the face are not same; this study will be performed as a randomized clinical trial in Tehran. 20 patients between 15 to 65 years after having a laser in the form of wounds that are similar, will be selected through available sampling and dermatologist consultation. Patients will first be examined by a specialist physician and will be introduced if they are eligible to enter the study. To modify any potential confounding in the study, any person who participated in the study will be in the control group also in the intervention group. In that way, one side of the face will be intervention and one side of the face will be controlled. Everyone has a red LED (interference) LED lamp and an LED lamp with white light (flashlight) without heat generation (laser and laser shading). The appearance of both will be the same and will only be number one and two. We ask the person to use the device number 1 only on the right side of face and the device number 2 on the left side of face. we will ask the patient to use the devices twice daily in the morning and at night each time for 5 minutes for seven days. It is necessary to explain that for both sides of the face, the usual treatments are in the form of topical ointment mupirocin twice daily in the morning and in the evening and oral capsule cephalexin 500 mg every 6 hours to 3 days and oral tablet acyclovir 400 mg every 8 hours to three days is used; in fact, red light will only be added to the routine treatment. It is expected that if there is a change in the wound healing process, it is because of Red LED Light. Starting day was considered zero, the wound will be taken on this day and on days 3, 5 and 7 (size of wound length and width) with using a digital camera.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710048146N25
Registration date:2017-10-14, 1396/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-14, 1396/07/22
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Red light LED ( 625 nm Wavelength) with white light LED on post- co2 laser wound healing
Public title
Comparing the effect of Red light with white light on post- co2 laser wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 15 years of age and under the age of 65; any patient that received equal fractional CO2 laser on both sides of face that due to acne scarring or rejuvenation; signature consent form; Exclusion criteria: age below 15 years and over 65 years; co2 laser with different parameters; wounds are not very standard and good for study; on both sides of face the energies and the number of laser passes are not the same and the wounds on both sides of the face are not same;
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2017-09-17, 1396/06/26
Ethics committee reference number
IR.SBMU.REC.1396.138
Health conditions studied
1
Description of health condition studied
co2 laser wounds
ICD-10 code
L59
ICD-10 code description
Other disorders of skin and subcutaneous tissue related to radiation
Primary outcomes
1
Description
Wound healing rate
Timepoint
Day 3, Day 5, Day 7 after treatment
Method of measurement
Camera and visio face
Secondary outcomes
empty
Intervention groups
1
Description
Control group: On one side of the face with a light-emitting diode (flashlight) lamp without heat, twice a day in the morning and at night 5 minutes for seven days. Normal treatment is in the form of topical mupirocin ointment One day twice in the morning and in the evening, and oral cefalexin 500 mg every 6 hours to 3 days and oral acyclovir 400 mg every 8 hours to 3 days.
Category
Placebo
2
Description
Intervention group: On the other side of the face with a red light LED (intervention), twice daily in the morning and at night,5 minutes for seven days . Normal treatment is performed simultaneously with topical mupirocin ointment twice a day In the morning and at night and oral capsules Cephalexin 500 mg every 6 hours to 3 days and oral tablet Acyclovir 400 mg every 8 hours to 3 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.Behrouz Barikbin
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
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,Shahid Beheshti 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
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Behrooz Barikbin
Position
dermatologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Behrooz Barikbin
Position
dermatologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Behrooz Barikbin
Position
dermatologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)