Safety and efficacy assessment of injectable gel containing stabilized hyaluronic acid with Perleux® brand, in order to rejuvenate and improve facial skin elasticity and hydration
Determining of Safety and efficacy assessment of injectable gel containing stabilized hyaluronic acid with Perleux® brand, in order to rejuvenate and improve facial skin elasticity and hydration
Design
The study is a phase 2 before-after clinical trial. The sample size is 20. The study was not randomized.
Settings and conduct
The study will be conducted in center for research and training in skin diseases and leprosy, Tehran university of medical sciences. Participants will be treated in one injection sessions with injectable gel containing stabilized hyaluronic acid with Perleux® brand. Assessment will be performed before first treatment, 8 and 16 week after treatment including improvement assessment using digital face photography and measurement the skin hydration and skin elasticity.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 35 -60 years old men and women. The presence of visible signs of skin aging mainly dry skin, skin roughness, loss of elasticity and clear lines and wrinkles. Have signed the informed consent form and agree to a 6-month follow-up.
Exclusion criteria: Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment, History of radiofrequency (R-F), rejuvenation lasers or intense pulsed light in the past 6 months, Pregnancy or lactation
Intervention groups
One injection with 2 ccstabilized hyaluronic acid with Perleux® brand. The product is 2cc prefilled sterilized syringe containing: 32 mg Hyaluronic Acid with high molecular weight+ 32 mg Hyaluronic Acid with low molecular weight from sodium hyaluronic acid salt in 2 ml soluble physiological buffer sodium chloride.
Main outcome variables
Skin elasticity (R0, R2, R5) measured in right cheek
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N17
Registration date:2022-12-06, 1401/09/15
Registration timing:prospective
Last update:2022-12-06, 1401/09/15
Update count:0
Registration date
2022-12-06, 1401/09/15
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of injectable gel containing stabilized hyaluronic acid with Perleux® brand, in order to rejuvenate and improve facial skin elasticity and hydration
Public title
Safety and efficacy assessment of injectable gel with Perleux® brand, in order to rejuvenate facial skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
35 -60 years old men and women
The presence of visible signs of skin aging mainly dry skin, skin roughness, loss of elasticity and clear lines and wrinkles.
Have signed the informed consent form and agree to a 6-month follow-up
Exclusion criteria:
Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment
History of radiofrequency (R-F), rejuvenation lasers or intense pulsed light in the past 6 months
Pregnancy or lactation
Age
From 35 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-11-26, 1401/09/05
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.083
Health conditions studied
1
Description of health condition studied
Skin Hydration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin elasticity (R0, R2, R5) measured in right cheek
Timepoint
Before intervention, 8 and 16 weeks later
Method of measurement
By cutometer probe of MPA 580(Multi Probe Adaptor) device
Secondary outcomes
1
Description
Thickness and density of dermis
Timepoint
Before intervention, 8 and 16 weeks later
Method of measurement
Skin ultrasound
2
Description
Trans Epidermal Water Lost (TEWL) measured in right cheek
Timepoint
Before intervention, 8 and 16 weeks later
Method of measurement
By TEWA probe of MPA 580(Multi Probe Adaptor) device
Intervention groups
1
Description
Intervention group: One injection with 2 ccstabilized hyaluronic acid with Perleux® brand. The product is 2cc prefilled sterilized syringe containing: 32 mg Hyaluronic Acid with high molecular weight+ 32 mg Hyaluronic Acid with low molecular weight from sodium hyaluronic acid salt in 2 ml soluble physiological buffer sodium chloride.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences