Safety and efficacy evaluation of Ignite microknife device, made by Medaria company in rejuvenation and improvement of facial sagging symptoms
Phase 2
Recruiting
- Conditions
- Skin aging.
- Registration Number
- IRCT20210130050179N4
- Lead Sponsor
- Maya Slim Ariya Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?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 Outcome Measures
Name Time Method 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.