Effectiveness of carboxytherapy in treatment of dark circle under the eyes
Design
One group clinical trial consisted of 20 patients who enrolled between December and September 2018 and followed for 3 months.
Settings and conduct
This study was done among patients complained of darkening of the eye, attending skin clinic of Tehran Rasoul-e-Akram hospital. There wasn’t blinding in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 20 to 50 years; male or female referring to the dermatology clinic for any reason with eye dark circle; Patients should have bilateral; symmetrical eye dark circle.
Non inclusion criteria: Botox injections during the past 6 months; receiving treatment; history of systemic disease; history of keloid formation; infected site.
Intervention groups
For 20 patients with under eyes dark circles, Carboxytherapy was administered as following: intradermal injection of 10-20 cc CO2 gas, rate: 20 cc/minute, angle: 15 degree, maximum 1 minute, duration: 4 sessions once a week. Patients followed 2 months later after last session with visioface camera.
Main outcome variables
Dark under eye circle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191219045826N1
Registration date:2020-02-12, 1398/11/23
Registration timing:retrospective
Last update:2020-02-12, 1398/11/23
Update count:0
Registration date
2020-02-12, 1398/11/23
Registrant information
Name
aboozar shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4224 0028
Email address
dr.a.shafeie55@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-24, 1397/11/04
Expected recruitment end date
2019-04-14, 1398/01/25
Actual recruitment start date
2019-01-29, 1397/11/09
Actual recruitment end date
2019-04-14, 1398/01/25
Trial completion date
2019-04-14, 1398/01/25
Scientific title
Evaluation of the effectiveness of Carboxytherapy in treatment of eye dark circle
Public title
Effect of co2 gas in treatment of eye dark circle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symetrical eye dark circle
Bilatral eye dark circle
Age of 20 to 50 years old
Exclusion criteria:
Give treatment
History of keloid formation
Have systemic disease
Botax injection since 6/m ago
Age
From 20 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
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 Shiraz University of Medical Sciences
Street address
Shahid Faghihi hospital, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Approval date
2019-01-25, 1397/11/05
Ethics committee reference number
IR.SUMS.MED.REC.1397.342
Health conditions studied
1
Description of health condition studied
Dark under eye circles
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dark under eye circles
Timepoint
Befor gaz injection then 2 month after last injection
Method of measurement
visioface delta E scale
Secondary outcomes
empty
Intervention groups
1
Description
Twenty consecutive eligible patients with DECs selected to enter the study and received carboxytherapy as injection of once weekly intradermally 10 to 20 cc of CO2 gas at a rate of 20 cc per minute with angle of 15 degree to the orbital skin, for maximum 1 minute (usually few seconds), to appear skin swelling, erythema or occurrence of pain. The total number of therapies was 4 sessions with 1 week interval and patients followed 2 month later after last session of carboxytherapy. Patients were photographed by VisioFace® 1000 D - Courage - Khazaka Electronic.The data was recorded as quantitative values based on ΔE (the difference between pigmentation in different parts of pigmented orbit skin (lateral and middle and medial) with adjacent normal skin of extra-orbital area), which was calculated by VisioFace device. The name of carboxytherapy was carbocure and manufactured by ronak tajhiz ara in iran .Concentration of co2 gas was 99% .
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul-e Akram Hospital
Full name of responsible person
Elham Behrangi
Street address
Hazrate Rasoole Akram Hospital, Niayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
Hrmc@iums.ac.ir
Web page address
Https://hrmc@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yones Ghasemi
Street address
Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Fax
Email
Info@sums.ac.ir
Web page address
Http://sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Aboozar Shafiei
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Before reaching Imam Hossein square, Zand street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 4224 0028
Fax
Email
dr.a.shafeie55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aboozar Shafiei
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Before reaching Imam Hossein square, Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 4224 0028
Fax
Email
dr.a.shafeie55@gmail.com
Web page address
https://sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aboozar Shafiei
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Before reaching Imam Hossein square, Zand street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Phone
+98 71 4224 0028
Fax
Email
dr.a.shafeie55@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available