Comparison effect between carboxytherapy and plasma rich platelet for treatment of periocular hyperpigmentation
Design
Clinical trial with parallel groups, single blind, non random in 20 patient
Settings and conduct
The study population was selected through convenience sampling until achieving the aimed number of the cases. After that, each side of the face was randomly treated with whether A approach or B approach. Carboxytherapy was considered as group A, and plasma-rich platelet as group B. facial side allocation to the approaches was performed using Random Allocation software in a way that each side of the face was provided with number one or two. The side with the random number one underwent Carboxytherapy, and number two underwent PRP. The injections were performed intradermally in the space lying within a centimeter under lower eyelid and amount of 0.2-0.3 cc in each point of injection.
The two dermatologists who interpreted the photographs were blinded to the type of approach used for each side of the face. Besides, in order to prevent bias, they were unaware that a photograph was taken preoperatively or postoperatively
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 20-65 y/o; 3-4 Fitzpatrick skin type.
Exclusion criteria: history of internal medical diseases; history of platelet disorders; smoking; lactating or pregnancy; patients' unwillingness of participation in the study; use of other therapeutic approaches.
Intervention groups
In the current clinical trial, number of 20 patients with POH underwent carboxytherapy was performed by intradermal injection carbon-dioxide gas once weekly for six weeks. The PRP treatment was performed by intradermal injection of PRP in periorbital space every two weeks for three times.
Main outcome variables
Score of periocular hyperpigmentation
General information
Reason for update
Acronym
PRP: Plasma rich platelet
IRCT registration information
IRCT registration number:IRCT20210130050181N1
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Akramsadat Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3653 3805
Email address
sadatamiri1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Plasma-rich platelet veruss carboxytherapy for the treatment of periocular hyperpigmentation; which approach is superior?
Public title
Plasma-rich platelet veruss carboxytherapy for the treatment of periocular hyperpigmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3-4 Fitzpatrick skin type
Age 20-65 years old
Exclusion criteria:
History of internal medical diseases(e.g., no previous history of cardiac, liver and/or renal diseases, diabetes mellitus, and thyroid dysfunction
History of platelet disorders and/or coagulopathy
Smoking and/or addiction
Lactating or pregnancy
Patients' unwillingness of participation in the study
Use of other therapeutic approaches
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Each side of the face was randomly treated with PRO and carboxytherapy
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The two dermatologists who interpreted the photographs were blinded to the type of approach used for each side of the face.
Besides, in order to prevent bias, they were unaware that a photograph was taken preoperatively or postoperatively.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.MUI.MED.REC.1397.300
Health conditions studied
1
Description of health condition studied
Periocular hyperpigmentation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of periocular hyperpigmentation
Timepoint
Before and within eight weeks after study performance
Method of measurement
Visual analog scale score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Carboxytherapy was performed by injection of carbon dioxide gas once weekly for six weeks. The amount of 5cc of CO2 was intradermally injected at the one-third lateral part of each eyelid using a 30-gauge needle with a velocity of 50 cc per minute.
Category
Treatment - Other
2
Description
Intervention group: The other side of the face was treated using one cc of PRP injected in periorbital space using an insulin syringe every two weeks for three times. The injections were performed intradermally in the space lying within a centimeter under lower eyelid and amount of 0.2-0.3 cc in 1.5-2 mm depth in each point of injection. The sites of injections were 1 centimeter apparent to the other ones.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al_Zahra hospital
Full name of responsible person
Akram Sadat Amiri
Street address
Al_Zahra hospital, Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3653 3805
Email
sadstamiri1367@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3653 3805
Email
sadatamiri1367@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Akram Sadat Amiri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Alzahra Hospital, Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
8174676431
Phone
+98 31 3653 3805
Email
sadstamiri1367@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Al Zahra hospital, Hakim Nezami Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3653 3805
Email
f_mokhtari2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Akram Sadat Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Alzahra Hospital, Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3653 3805
Email
sadatamiri1367@Gmail.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
Due to security of patient secret
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