Determination of the efficacy and side effects of QS Nd-yag laser in comparison with carboxy therapy in the treatment of dark circles
Design
The aim of this study is to evaluate the efficacy and side effects of QS Nd-yag laser in comparison with carboxy therapy in the treatment of dark circles. Twenty-eight patients with dark circles are randomly assigned to blocked randomization and are divided into two groups: carboxy-therapy, or Nd-yag switch-over treatment group.
Settings and conduct
Patients with eye dark circles that are referred to the skin and stem cell research center enter into two groups of carboxytherapy and laser intervention. In the carboxytherapy group after local anesthesia, injection is done intradermally every week, the total volume of injection in each side is one or two milliliters. The treatment sessions are held every six weeks for six sessions.The laser treatment group will receive three to four sessions of QS Nd-yag laser treatment with a certain frequency, one-month intervals. Patients are evaluated at baseline, at the end of treatment, and 3 months later.The pigmentation changes are evaluated by the Mexameter, and the brightness of the skin is measured with a calorimeter.Photographs are taken with visioface and photos of sessions 0, 4 and 6 are reviewed by two blind dermatologists. Patient satisfaction and side effects are analyzed and compared.
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
First intervention group: the circular darkness is treated with QS Nd-yag laser.
Second intervention group: the dark circles of the eye are treated with carboxytherapy.
Main outcome variables
Melanin Index; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N24
Registration date:2019-07-31, 1398/05/09
Registration timing:retrospective
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of carboxy therapy in comparison with fractional Q-Switched ND:YAG laser for the treatment of periorbital dark circles
Public title
Carboxy therapeutic effectiveness in comparison with fractional Q-Switched ND:YAG laser for the treatment of periorbital dark circles
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:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method (n=4)
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
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
2018-10-20, 1397/07/28
Ethics committee reference number
IR.TUMS.VCR.REC.1397.607
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
The first Intervention group: the darkness around the eyes treated with QS Nd-yag laser, 4 sessions with one-month interval.
Category
Treatment - Other
2
Description
Second intervention group: Round-eye darkness Six sessions with a one-week interval are treated with carboxytherapy.
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
Nahid Nickhah
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nahid_nickhah@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
100
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
Nahid Nickhah
Position
Associate professor
Latest degree
Specialist
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
Nahid_nickhah@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
Specialist
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
Reproductive 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