The study population is selected from those who refer to the skin clinic. Sampling was randomly selected based on the inclusion criteria from clients with a complaint of nearsightedness and the approval of a dermatologist and the acceptance of informed consent to participate in the project. Phase III is limited to 31 patients.
Settings and conduct
Dermatology Clinic TUMS BRANCH OF ACECR
Participants/Inclusion and exclusion criteria
The cause of darkness is not due to weight loss or anatomical problems in this area.
- Age between 20 and 50 years, including men and women, with a complaint of dark circles around the eyes and a dermatologist's confirmation
- Do not have a history of cancer
- Patients should not be pregnant or breastfeeding
- Do not have uncontrolled or acute cardiovascular diseases (uncontrolled blood pressure).
- Do not have acute respiratory diseases and pulmonary embolism that occurred recently
- Do not have blood coagulation problems (such as hemophilia).
- There should be no active infection in the area
- Don't have connective tissue diseases
- Uncontrolled diabetes
- Do not have a history of keloid
- No botox injection in the last month
Exclusion criteria:
If any of the conditions for entering the study are not met during four sessions of carboxytherapy for patients (an active infection develops, the mentioned diseases occur during this period, the patient becomes pregnant, etc.), the patient will be excluded from the study.
Intervention groups
27 patients with blepharitis and dermatological confirmation
Main outcome variables
The main result is the reduction of darkness around the eyes in different treatment sessions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150822023706N3
Registration date:2023-02-05, 1401/11/16
Registration timing:retrospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Afshan Shirkavand
Name of organization / entity
Medical Laser research center
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 2915
Email address
ashirkavand@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of carboxytherapy in treatment of periorbital dark circles: A limited phase-3 study
Public title
Evaluation of the effects of carboxytherapy in treatment of periorbital dark circles: A limited phase-3 study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no weight loss
20-50 years
no cancer history
no pregnant and feeding
no hypertension
no respiratory syndromes
no coagulant disorders
no active infections
no tissue transplantation
no uncontrolled diabet
no keloid history
no botox
Exclusion criteria:
exist of any inclusion criteria
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
two dermatologists evaluate VAS changes of DECs as blinded evaluation.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Motamed INSTITTUTE , ACECR
Street address
No.17 Nazari street
City
Tehran
Province
Tehran
Postal code
1315795613
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR-ACECR-IBCRC-REC.1400.011
Health conditions studied
1
Description of health condition studied
dark eye circle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Darkness scores at the end of treatment or in different sessions
Timepoint
Before treatment - after the first, second and third session
Method of measurement
Based on VAS (Visual Analogue Scale) satisfaction criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: carboxy therapy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
yara institute
Full name of responsible person
Dr.Seyed Mehdi Tabaie
Street address
nO.17 Nazari st
City
Tehran
Province
Tehran
Postal code
1315795613
Phone
+98 21 6646 2519
Email
smtabaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yara institute
Full name of responsible person
Dr. Seyed Mehdi Tabaie
Street address
No.17 Nazari st
City
Tehran
Province
Tehran
Postal code
1315795613
Phone
+98 21 6646 2519
Email
smtabaie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yara institute
Proportion provided by this source
100
Public or private sector
Private
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
YARA institute
Full name of responsible person
Dr Seyed Mehdi Tabaie
Position
associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
n0.17 nazari st
City
Tehran
Province
Tehran
Postal code
1315795613
Phone
+98 21 6646 2519
Email
smtabaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
YARA institute
Full name of responsible person
Dr Seyed Mehdi Tabaie
Position
associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
n0.17 nazari st
City
Tehran
Province
Tehran
Postal code
1315795613
Phone
+98 21 6646 2519
Email
smtabaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr Seyed Mehdi Tabaie
Position
associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
n0.17 nazari st
City
Tehran
Province
Tehran
Postal code
1315795613
Phone
+98 21 6646 2519
Email
smtabaie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
private data of the patients
Study Protocol
No - There is not 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