Under-eye rejuvenation.
Conditions
Interventions
Intervention 1: Intervention group: Intervention group (Fractional CO2 laser + SVF injection):Participants in this group will receive one session of fractional CO2 laser treatment, followed by stromal
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants must be between 18 and 60 years of age The skin in the infraorbital (under-eye) area must be healthy, with no evidence of infection, wounds, or suspicious lesions The skin at the fat harvest site must be healthy, with no evidence of infection, wounds, or suspicious lesions Participants must not have uncontrolled systemic diseases, including cardiac or respiratory failure, or uncontrolled diabetes mellitus Participants must not be using anticoagulant medications Participants must be willing and able to provide written informed consent and comply with the study protocol, including follow-up visits and pre-/post-treatment restrictions Female participants must not be pregnant or breastfeeding Participants must not have received any treatment in the under-eye area (such as filler injections, rejuvenation procedures, laser therapy, or lifting procedures) within the past year
Exclusion criteria
Exclusion criteria: The participant has a history of keloid formation The participant has a history of coagulation disorders or is using medications that affect blood coagulation The participant has uncontrolled diabetes mellitus or uncontrolled hypertension The participant has had an active infection in the facial area within the past month The participant is unwilling or unable to attend follow-up visits at the scheduled times The participant has a history of inherited or acquired connective tissue diseases The participant has a history of skin cancer within the past five years The participant has unrealistic expectations regarding the treatment outcomes The participant has used other facial rejuvenation procedures, including laser therapy, filler injections, or botulinum toxin injections, within the past six months The participant has a known hypersensitivity to lidocaine or tetracaine The participant has a Fitzpatrick skin type greater than IV The participant has a history of inflammatory skin diseases such as lichen planus or eczema The participant has a history of sunburn or skin tanning within the past two months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving wrinkles or skin quality under the eyes. Timepoint: Baseline (before treatment initiation)Second and third treatment sessions (at one-month intervals)One month after the last treatment session (first follow-up)Three months after the last treatment session (second follow-up). Method of measurement: The variable will be evaluated using two methods: objective and subjective.Objective method:Standardized digital photographs will be taken before and after treatment and evaluated by two independent dermatologists blinded to group allocation. Improvement will be reported as a percentage (0–100%).Classification of response:Low response: 0–25% improvementMild response: 25–50% improvementModerate response: 50–75% improvementExcellent response: >75% improvementSubjective method:Adverse events (such as edema, pain, erythema, itching, blistering, hypopigmentation, hyperpigmentation, scarring, etc.) and patients’ satisfaction with treatment outcomes will be recorded and analyzed.Objective assessment procedure:Standardized digital photography (fixed lighting, angle, distance, and uniform background)Image evaluation by two blinded dermatologistsIn case of more than one-grade discrepancy, a third expert’s opinion will be considered finalSubjective assessment procedure:Recording patients’ satisfaction with treatment outcomes through direct questioningRecording adverse events at each visit using adverse event reporting forms and clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSanaz salemianpoor
Shahid Beheshti University of Medical Sciences
Outcome results
None listed