To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging
- Conditions
- Facial aging.
- Registration Number
- IRCT201507226135N5
- Lead Sponsor
- Medaria Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
•Aged between 30 to 60 years.
•Mild to moderate (Glogaue Score)
•Skin Type (II-IV)
•Signed informed consent voluntarily and knowingly
Exclusion criteria
•History of any implant in face area
•History of any cosmetic surgery during last 3 years in face area
•History of RF during last year
•History of any Botulinum, laser, or intense pulsed light during last 6 month
•History of Isotretinoin during last 6 month
•Collagen vascular disease
•Diabetes
•Severe cardiac disease
•Malignant tumor
•Bleeding disorders, Coagulopathy, any drugs affect bleeding time
•Any active, chronic and recurrent infection
•Any history of anaphylaxis
•Susceptibility to keloids
•Any active or recurrent herpes
•Any immune-compromised conditions
•Skin atrophy
•Active smoker ( last 2 years)
•Pregnancy/ breast feeding
•Vascular disease
•Cardiac pace maker
•Vertigo, labyrinthitis
•Dyslipidemia
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wrinkle. Timepoint: At baseline- 1 week, 3 months and 6 months after the last treatment session. Method of measurement: Two board-certified dermatologists will perform clinical assessments in a blinded fashion by scoring every photograph according to the Fitzpatrick wrinkle scale.;Laxity. Timepoint: At baseline- 1 week, 3 months and 6 months after the last treatment session. Method of measurement: Two board-certified dermatologists will perform clinical assessments in a blinded fashion by scoring every photograph according to the Alexiades-Armenakas laxity scale.
- Secondary Outcome Measures
Name Time Method