Comparison of side effects (sensitivity and redness, tissue necrosis, accumulation of mass under the skin) caused by injection of Hyaluronic Acid dermal fillers of two brands, Restylane and Perfectha, under the eye area of patients referred for skin rejuvenation.
Comparison and determination of side effects caused by the injection of hyaluronic acid dermal fillers of two brands,Restylane and Perfectha, under eye area among patients referred to Amirul Mominin Hospital in 2023 in Tehran
Design
Clinical trial, with parallel groups, single-blind, non-randomized, phase 4 on 86 patients.
The clinical trial has two intervention groups of 43 people, group number one receiving Restylane filler and group number two receiving Perfectha filler in the under eye area.
Settings and conduct
The place of study: Dermatology department of Amir Al-Mominin Hospital in Tehran. The study population: patients referred for skin rejuvenation. Blinding: not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: complete patient information; informed Consent; Age over 18 years and under 70 years.
Exclusion criteria:
Presence of underlying disease; History of similar injections in the past under the eyes
Intervention groups
Intervention group 1: Recipient of Restylane filler, 0.5 to 1 ml of filler is injected with a 32 gauge needle in the orbit rim. Intervention group 2: recipient of Perfecta filler, 0.5 to 1 ml of filler is injected with a 32-gauge needle in the orbital rim.
Main outcome variables
sensitivity and redness; Mass accumulation under the skin; skin necrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058912N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Ensie Keshvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3371 4516
Email address
keshvari75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of side effects (sensitivity and redness, tissue necrosis, accumulation of mass under the skin) caused by injection of Hyaluronic Acid dermal fillers of two brands, Restylane and Perfectha, under the eye area of patients referred for skin rejuvenation.
Public title
Comparison of side effects caused by injection of Hyaluronic acid dermal fillers of two brands, Restylane and Perfectha, in the under eye area
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hyaluronic acid injection in the under eye area
age between 18 to 70
informed consent
Exclusion criteria:
History of bleeding diseases
History of eye surgery in the last month
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in both groups remain unaware of the treatment method allocation during the study. The patient is informed that there are two types of hyaluronic acid gel brands in a study and they will receive one of them randomly. Patients remain unaware of the name of the treatment method assigned to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences
Street address
Tehran branch of Islamic Azad University of Medical Sciences, Khaghani st, Shariati st
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.IAU.TMU.REC.1402.045
Health conditions studied
1
Description of health condition studied
Complications caused by injecting hyaluronic acid dermal fillers in the under eye area
ICD-10 code
T50.995
ICD-10 code description
Adverse effect of other drugs, medicaments and biological substances
Primary outcomes
1
Description
Inflammation and redness of the area based on the dermatologist examination
Timepoint
7 days, one month and two months after hyaluronic acid injection
Method of measurement
The opinion of two dermatologist separately
2
Description
Mass accumulation under the skin
Timepoint
7 days, one month and two months after hyaluronic acid injection
Method of measurement
The opinion of two dermatologist separately
3
Description
skin necrosis
Timepoint
7 days, one month and two months after hyaluronic acid injection
Method of measurement
The opinion of two dermatologist separately
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: the group of 43 people receiving Restylane filler, Restylane filler, which is made of non-animal hyaluronic acid and is produced by a Swedish company in packages of one milliliter volume, in the amount of half to one milliliter depending on the needs of the patients. We inject in the orbital rim using a 32-gauge needle or cannula within twenty minutes.
Category
Treatment - Drugs
2
Description
The second intervention group: the group of 43 people receiving Perfecta filler, Perfecta filler is made of non-animal hyaluronic acid and is produced by a French company in packages of one milliliter volume, half to one milliliter depending on the needs of the patients. We inject the orbital rim using a 32-gauge needle or cannula within twenty minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Ensie Keshvari
Street address
Shirmohammadi street, Nazi-abad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
amhos@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
No 403, Tehran West Unit Building, َAyeneh Blvd., Pabarja St., Qolhak Road, Shariati St., District 3
City
Tehran
Province
Tehran
Postal code
1774684343
Phone
+98 912 202 4729
Email
keshvari75@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?