Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation and improvement of facial skin elasticity and hydration
Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation and improvement of facial skin elasticity and hydration
Design
Phase II single group. before -after, clinical study
Settings and conduct
The study will be conducted in center for research and training in skin diseases and leprosy. participants will be treated in 4 Injection sessions with Luxiva brand skin mesotherapy solution. assessment will be performed before first treatment, one month after the last injection (day 90) and 2 months after the last injection (day 120) including improvement assessment using digital face photography and measurement the skin hydration and skin elasticity.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 35 and 60 years old; present visible signs of skin ageing symptoms mainly skin dryness skin roughness; loss of elasticity and appearance of fine lines; possibility to accompany the visit plans and study process; signing an informed consent form and agreed to follow up.
Exclusion criteria: previous treatment with hyaluronic acid fillers in the facial area within the past year; experience with RF, rejuvenation lasers or intense pulsed light in the past 6 months; systemic diseases affecting skin health such as collagen vascular diseases, diabetes, hypothyroidism, as well as liver and renal failure.
Intervention groups
4 sessions with 4 cc sterile solution of Luxiva injection mesotherapy. The intervals for the first three injections are done at the beginning of every two weeks and the fourth injection, one month after the third injection. Luxiva injection solution is sterile and contains hyaluronic acid 20 mg/vial amino acid alanine, arginine, etc.
Main outcome variables
Skin elasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N25
Registration date:2023-11-12, 1402/08/21
Registration timing:prospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
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
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation and improvement of facial skin elasticity and hydration
Public title
Clinical evaluation of the efficacy and safety of Luxiva brand skin mesotherapy solution for rejuvenation of facial skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35 and 60 years old
Present visible signs of skin ageing symptoms mainly skin dryness skin roughness, loss of elasticity and appearance of fine lines
Possibility to accompany the visit plans and study process.
Signing an informed consent form and agreed to follow up.
Exclusion criteria:
Previous treatment with hyaluronic acid fillers in the facial area within the past year
Experience with RF, rejuvenation lasers or intense pulsed light in the past 6 months
Systemic diseases affecting skin health such as collagen vascular diseases, diabetes, hypothyroidism, as well as liver and renal failure.
History of systemic use of skin-related medicine such as glucocorticoids, isotretinoin, immunomodulators and hormonal medicine in the past 3 months
Currently pregnant or lactating
Smoking in the past two years
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
2023-11-11, 1402/08/20
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.100
Health conditions studied
1
Description of health condition studied
Skin hydration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin elasticity
Timepoint
Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120)
Method of measurement
Cutometery
Secondary outcomes
1
Description
Stratum corneum hydration
Timepoint
Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120)
Method of measurement
Corneometry by MPA 580
2
Description
Skin condition for signs of skin aging including clear lines and wrinkles
Timepoint
Before intervention, one month after the last injection (day 90) and 2 months after the last injection (day 120)
Method of measurement
Using GAIS scale
Intervention groups
1
Description
Intervention group: 4 sessions with 4 cc sterile solution of Luxiva injection mesotherapy. The intervals for the first three injections are done at the beginning of every two weeks and the fourth injection, one month after the third injection. Luxiva injection solution is sterile and contains hyaluronic acid 20 mg/vial amino acid alanine, arginine, etc.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy