Evaluation of the efficiency and safety of the RF Fractional microneedling system of Beaty skin device made by Faragard Fanavari Company in rejuvenating and improving the signs of aging facial skin
Evaluation of the efficiency and safety of the RF Fractional microneedling system using Beauty skin device made by Faragard Fanavari Company in rejuvenating and improving the signs of facial skin aging
Design
Single group, phase 2, before -after clinical study on 20 participants.
Settings and conduct
The study will be performed in Center for Research and Study in skin Diseases and Leprosy. 20 healthy volunteers will be selected and enrolled in the study after signing consent form. Two treatment sessions will be performed using Beaty skin device made by Fanavari faragard Company. Each session will be taken 45 minuets. Skin photography and measurement of skin biophysical parameters (including skin elasticity, area and volume of wrinkles as well as ultrasound parameters) will be performed before treatment, as well as 1 and 8 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mild to moderate wrinkles or sagging facial skin based on Glogau scale, Signing the consent form
Exclusion criteria: History of using any silicone, fat, collagen, hyaluronic acid or synthetic materials implant on face, History of RF treatment during the past year, History of Botox injection in face within the past 6 months, using Isotretinoin in the last 6 months, Active smoker in last 2 years, pregnancy or lactating
Intervention groups
2 sessions treatment with RF Fractional microneedling probe of Beauty skin device
Main outcome variables
Changing in facial skin wrinkles, using Glogau scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N11
Registration date:2020-11-18, 1399/08/28
Registration timing:retrospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficiency and safety of the RF Fractional microneedling system of Beaty skin device made by Faragard Fanavari Company in rejuvenating and improving the signs of aging facial skin
Public title
Anti aging efficacy of radiofrequency system of Beaty skin device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mild to moderate wrinkles or sagging facial skin based on Glogau scale
Signing the consent form for participation in the study
Exclusion criteria:
History of any implant placement including silicone, fat, collagen, hyaluronic acid or synthetic materials on face
History of using RF during the past year
History of Botox injection in face within the past 6 months
Isotretinoin use in the last 6 months
Active smoker in last 2 years
Pregnancy or lactating
Age
From 30 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 Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.TUMS.VCR.REC.1398.762
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ّacial skin wrinkle grading, using Glogau scale
Timepoint
Before intervention and 1 and 8 weeks after last treatment session
Method of measurement
One independent dermatologist will perform clinical assessments using patients’ photographs according to the Glogau scale.
2
Description
Skin elasticity
Timepoint
Before intervention and 1 and 8 weeks after last treatment session
Method of measurement
Cutometery
Secondary outcomes
1
Description
Skin thickness and density
Timepoint
Before intervention and 1 and 8 weeks after last treatment session
Method of measurement
Skin ultrasound
2
Description
Area and volume of nasolabial fold
Timepoint
Before intervention and 1 and 8 weeks after last treatment session
Method of measurement
VisioFace camera
Intervention groups
1
Description
Intervention group: 2 sessions of full face treatment with RF Fractional microneedling probe of Beauty skin device. intensity 7 out of 10, active puls count 200 --250, depth 1 mm and time interval 1.5 second
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy