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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210130050179N4

Enrollment

Registered

2022-09-18

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin aging.

Interventions

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 p

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
?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.;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.	—

Measure

Time frame

?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.;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

Measure	Time frame
Area and volume of nasolabial fold. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: VisioFace device.;Skin thickness and density. Timepoint: Before intervention, 4 and 8 weeks after treatment. Method of measurement: Skin ultrasound.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTaraneh Yazdanparast

Tehran University of Medical Sciences

drtaraneh@yahoo.com+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026