Facial Skin Aging.
Conditions
Interventions
Intervention 1: Intervention group: On the assigned intervention side, treatment will be performed using a High-Intensity Focused Ultrasound (HIFU) device, model Doublo Gold, manufactured by Nik Laser
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age between 30 to 65 years No facial rejuvenation procedures within the past 6 months.
Exclusion criteria
Exclusion criteria: History of keloid or hypertrophic scar Active skin diseases (psoriasis, vitiligo, lichen planus, lupus, herpes) History of solar urticaria Uncontrolled diabetes (controlled diabetes is acceptable with physician approval) Epilepsy Metallic implants in the treatment area (dental implants are not a limitation) Current use of anticoagulant drugs Acute fever or infection (including skin or fungal infection) Recent sunburn or tanning (within 20–25 days) Pregnancy Hyaluronic acid or botulinum toxin injection within the past 2–3 months Laser treatment within the past 1 month Recent dermal filler injection Autoimmune diseases Bell’s palsy asthma hypertension thyroid disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Assessment Scale (GAAS) score by the physician. Timepoint: Baseline (before intervention), 1 month post-intervention, 3 months post-intervention. Method of measurement: Clinical assessment by a blinded physician based on comparing standardized photographs at different time points. The GAIS score is a 5-point scale (5=very much improved, 4=improved, 3=no change, 2=worse, 1=very much worse).;Patient satisfaction score with treatment outcomes. Timepoint: 3 months post-intervention. Method of measurement: Self-administered questionnaire using a 5-point Likert scale (5=very satisfied, 4=satisfied, 3=neutral, 2=dissatisfied, 1=very dissatisfied). | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin elasticity (R2 parameter). Timepoint: At baseline (before intervention), 1 month post-intervention, 3 months post-intervention. Method of measurement: Measured by the Cutometer® MPA 580 device. The R2 parameter, which is representing the ability of the skin to return to its original state after suction, will be recorded.;Skin hydration of the stratum corneum. Timepoint: At baseline (before intervention), 1 month post-intervention, 3 months post-intervention. Method of measurement: Measured by the Corneometer® CM 825 device based on skin capacitance. Results are expressed in arbitrary units (A.U.).;Transepidermal Water Loss (TEWL) rate. Timepoint: Baseline (before intervention), 1 month, and 3 months post-intervention. Method of measurement: Measured by the Tewameter® TM 300 device. Results are recorded in grams per square meter per hour (g/m 2 /h) and indicate the skin barrier function.;Dermal thickness. Timepoint: Baseline (before intervention), 1 month, and 3 months post-intervention. Method of measurement: Measured using high-frequency ultrasound (20 MHz). Thickness is measured in millimeters (mm) from the dermal-epidermal junction to the dermal-hypodermal junction.;Echogenic density of the dermis. Timepoint: Baseline (before intervention), 1 month, and 3 months post-intervention. Method of measurement: Analysis of images from high-frequency ultrasound (20 MHz). Density is measured as the echo-intensity in the dermis, indicating collagen density.;Incidence and severity of adverse effects. Timepoint: Immediately post-intervention, 1 month, and 3 months post-intervention. Method of measurement: Clinical assessment and patient reporting for adverse effects such as erythema, edema, pain, bruising, and burns. Severity is graded on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShiva Alavi
Tehran University of Medical Sciences
Outcome results
None listed