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Safety and efficacy evaluation of "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms

Protocol summary

Study aim
Safety and efficacy evaluation of "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms
Design
It is a phase II interventional before-after clinical study. 21 healthy adult volunteers will participate in the study after signing informed consent. The study is not randomized.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy from Tehran University of Medical Sciences. Participants will treat on full face by "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company for one session.The assessments of Glogau criteria as well as skin biophysical parameters (skin elasticity, hydration, erythema, area and volume of nasolabial fold ,Skin thickness and density) will be performed before intervention, 4 and 8 weeks after treatment. The study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people aged between 30 to 60 years, People with facial skin wrinkles grade 2 and 3 based on Glogau scale and mild to moderate sagging (1 and 2) based on the Modified Fitzpatrick wrinkle criteria, Signing the informed consent form Exclusion criteria: History of using any type of device filler, including silicone, fat, collagen, hyaluronic acid or artificial materials in the treatment area, History of any type of cosmetic surgery during the last 3 years at the treatment area
Intervention groups
Intervention group: One session of full face treatment by "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company. Intervention will be as a complete pass by a facial microknife on the entire face, and a pass with a microhook will be performed on the nasolabial folds.
Main outcome variables
Facial skin wrinkle grading, using Glogau scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210130050179N4
Registration date: 2022-09-18, 1401/06/27
Registration timing: prospective

Last update: 2022-09-18, 1401/06/27
Update count: 0
Registration date
2022-09-18, 1401/06/27
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy evaluation of "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms
Public title
Safety and efficacy evaluation of Ignite microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged between 30 to 60 years People with facial skin wrinkles grade 2 and 3 based on Glogau scale and mild to moderate sagging (1 and 2) based on the Modified Fitzpatrick Wrinkle Criteria Signing the informed consent form
Exclusion criteria:
History of using any type of device filler, including silicone, fat, collagen, hyaluronic acid or artificial materials in the treatment area History of any type of cosmetic surgery during the last 3 years at the treatment area Use of Isotretinoin in the last 6 months Suffering from collagen vascular diseases, diabetes, severe heart diseases History of treatment by Radio Frequency (RF) during the last year
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: 21
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 in research of medical school-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
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.415

Health conditions studied

1

Description of health condition studied
Skin aging
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
ّfacial skin wrinkle grading, using Glogau scale
Timepoint
Before intervention, 4 and 8 weeks after treatment
Method of measurement
One independent dermatologist will perform clinical assessments using patients’ photographs according to the Glogau scale.

2

Description
Facial skin sagging based on Modified Fitzpatrick Wrinkle Criteria
Timepoint
Before intervention, 4 and 8 weeks after treatment
Method of measurement
One independent dermatologist will perform clinical assessments using patients’ photographs according to the Modified Fitzpatrick wrinkle scale.

Secondary outcomes

1

Description
Area and volume of nasolabial fold
Timepoint
Before intervention, 4 and 8 weeks after treatment
Method of measurement
VisioFace device

2

Description
Skin thickness and density
Timepoint
Before intervention, 4 and 8 weeks after treatment
Method of measurement
Skin ultrasound

Intervention groups

1

Description
Intervention group: One session of full face treatment by "facial microknife" and "microhook" of Ignite radio hybrid microknife device, made by Medaria company. Microknife intervention is a complete pass with a facial microknife on the entire face (Its surface is 15 x 15 mm and it has 35 needles with a penetration depth of 2.5 to 3 mm) and a pass with a microhook is performed on the nasolabial folds (The needles are like hooks and are locked when entering the skin).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy
Full name of responsible person
Taraneh Yazdanparast
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
drtaraneh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maya Slim Ariya Company
Full name of responsible person
Mostafa Farahi
Street address
No. 216, Dastgerdi Avenue, Bokhara Street.
City
Tehran
Province
Tehran
Postal code
918643471
Phone
+98 21 2222 2660
Email
externalaffairs@medariaco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maya Slim Ariya Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taraneh Yazdanparast
Position
Research Physician
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
drtaraneh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
firozali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Clinical Research
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
ahmadi.maryam648@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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