1. Home
  2. Approved trials
  3. » فارسی

Investigating the safety and efficacy of fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company, in rejuvenating facial skin

Protocol summary

Study aim
Investigating the safety and efficacy of fractional microneedle Sophia device, manufacturde by Parnian Gostar Radiometer Company, in rejuvenating facial skin
Design
Single group, phase 2, before -after clinical study on 21 participants.
Settings and conduct
The study will be performed in Center for Research and Study in skin Diseases and Leprosy. 21 healthy volunteers will be selected and enrolled in the study after signing consent form. Four treatment sessions will be performed using fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company. 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 4 and 8 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 30 to 60, 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 consent form for participation in the study 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
Intervention groups
4 sessions of full face treatment with fractional microneedle Sophia device, manufacturde by Parnian Gostar Radiometer Company as a complete pass on full face. The diameter of the needles in this system is equal to 120μm.
Main outcome variables
Facial skin wrinkle grading, using Glogau scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190210042676N26
Registration date: 2022-10-03, 1401/07/11
Registration timing: prospective

Last update: 2022-10-03, 1401/07/11
Update count: 0
Registration date
2022-10-03, 1401/07/11
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
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and efficacy of fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company, in rejuvenating facial skin
Public title
Investigating the safety and efficacy of fractional microneedle Sophia device, in rejuvenating facial skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 30 to 60 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 consent form for participation in the study
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
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 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
2022-09-10, 1401/06/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.431

Health conditions studied

1

Description of health condition studied
Skin ageing
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 last treatment session
Method of measurement
An independent dermatologist perform evaluation and scoring with the help of full face photos based on the percentage of improvement in facial wrinkles, using scale 1 to 4 (1 = no wrinkle 2 = Wrinkles in motion 3 = Wrinkles at rest 4 = Only wrinkles) .

Secondary outcomes

1

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

2

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

Intervention groups

1

Description
Intervention group: 4 sessions of full face treatment with fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company as a complete pass on full face. The diameter of the needles in this system is equal to 120μm.
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
Aniseh Samadi
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Parnian Gostar Radiometer Company
Full name of responsible person
Mahdi Zamanian
Street address
Unit 100, Aseman Vanak Official Tower, Vanak St.
City
Tehran
Province
Tehran
Postal code
1991945343
Phone
+98 21 8887 3479
Email
info@parniangostar.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Parnian Gostar Radiometer 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
Aniseh Samadi
Position
Clinical Lab Manager
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
aniseh_samadi@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) St., Taleqani Ave.
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) St., Taleqani Ave.
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
Loading...