Investigating the safety and efficacy of fractional microneedle Sophia device, in rejuvenating facial ski
Phase 2
Recruiting
- Conditions
- Skin ageing.
- Registration Number
- IRCT20190210042676N26
- Lead Sponsor
- Parnian Gostar Radiometer Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
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
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 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 Outcome Measures
Name Time Method Skin thickness and density. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: Skin ultrasound.;Area and volume of nasolabial fold. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: VisioFace camera.