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IRCT201507226135N5 IRCT 2015-07-24 Medaria Company To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging To evaluate the safety and efficacy of M3D Fractional - Made By Medaria in reducing facial aging: A single arm phase III clinical trial 2015-07-23 anticipated 15 Complete https://irct.ir/trial/6571 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Facial aging. Each patient will receive six sessions of m3D Fractional treatment to the whole face. The face will be thoroughly cleaned and dried before treatment. Treatment will be conducted by trained and experienced technician according to the instructions in m3D Fractional user manual. All subjects will be asked to use sunscreen with SPF 30 after each treatment session and to visit 1-week, 3- and 6-month after the last treatment session..
public
scientific Dr. Alireza Firooz
No. 415, Taleqani Ave.
Tehran Iran (Islamic Republic of) +98 21 8897 2220 firozali@tums.ac.ir Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: • 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 30 years 60 years Both Treatment - Devices Each patient will receive six sessions of m3D Fractional treatment to the whole face. The face will be thoroughly cleaned and dried before treatment. Treatment will be conducted by trained and experienced technician according to the instructions in m3D Fractional user manual. All subjects will be asked to use sunscreen with SPF 30 after each treatment session and to visit 1-week, 3- and 6-month after the last treatment session. 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. Patient's overall satisfaction. Timepoint: At the final treatment session and at 1-week, 3- month and 6- month after their final treatment session. Method of measurement: based on a 6-point Likert scale (0-No satisfaction, 1- very little satisfaction, 2-little satisfaction, 3-moderate satisfaction, 4-much satisfaction, 5- very much satisfaction). Skin elasticity. Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: Cutometer. Water content. Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: Corneometer. Transepidermal water loss. Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: TEWAmeter. Skin pigmentation. Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: Mexameter. Ultrasonographic measurements ( skin thickness and density). Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: Skin ultrasonography. Wrinkles and colour differences. Timepoint: At baseline and 1-week, 3- month and 6-month after the final treatment session. Method of measurement: VisioFace. Side-effects including erythema, edema, pain, hyperpigmentation and scarring). Timepoint: All visits. Method of measurement: By physician. Medaria Company Approved 2015-07-04 Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)