Determination of the efficacy and side effects of QS Nd-yag laser in the treatment of dark circles
Design
A clinical trial in phase 2, without control group and with an intervention group, comparable before and after, not blind, on 37 volunteers for treatment dark circles around the eyes.
Settings and conduct
This project is performed in the clinic of Skin and Stem Cell Research Center of Tehran University Medical Sciences and in the treatment of dark circles volunteers. Patients, if there are conditions for admission to the study, enter the study after obtaining written consent and are treated in the dark area around the eye by fractional QS Nd-yag laser. Each patient received 6 treatment sessions with 2 weeks interval (a total of 3 months of treatment). Also, the thickness and elasticity of the skin and the amount of pigment around the eyes are checked with a skin ultrasound device and cotometer and maxameter, before and one month after the end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-65 years old; the cause of darkness, structural and reducing fat in this area is not. Exclusion criteria: pregnancy or breastfeeding; active infection in face; history of cancer.
Intervention groups
Intervention group: the circular darkness is treated with QS Nd-yag laser
Main outcome variables
Melanin Index; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N31
Registration date:2021-01-10, 1399/10/21
Registration timing:registered_while_recruiting
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and side effects of fractional Q-Switched ND:YAG laser in the treatment of ophthalmia in patients
Public title
Evaluation of the effectiveness of Q-Switched ND:YAG laser in the treatment of facial skin lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The cause of darkness, structural and reducing fat in this area is not
Age between 18 and 65 years old
Exclusion criteria:
Active infection in the face
Pregnancy and breastfeeding
History of cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
37
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.TUMS.REC.1394.854
Health conditions studied
1
Description of health condition studied
Eye dark circles
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Preorbital hyperpigmentation
Timepoint
Session 0, 4 and 6 during treatment and 3 months after treatment
Method of measurement
Intensity of the darkening of the skin around the eyes compared to other areas of the face with Mexameter device.
2
Description
Satisfaction amount
Timepoint
After completion of treatment
Method of measurement
Comparison of reduction preorbital hyper pigmentation by patient , before and after treatment According to schedule ( score 0 to 10 )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive 6 fractions of treatment with 2 weeks interval (3 months in total) by QS Nd-yag laser. At each turn is done, two passes of 1000 joules on the peri-orbital areas.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Shiva Alavi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
Shiva.alavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ali Karimi
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Shiva Alavi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Shiva.alavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mona Mahmoudbeyk
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Developmental Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
mmahoodbeyk@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available