Facial skin laxity
Conditions
Interventions
High heat feedback:High energy - high heat feedback - few passes unipolar RF
Low heat feedback:Adopting low-energy, low heat feedback, multi pass unipolar RF
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 30 - 65 years (inclusive of 30 and 65); Gender not restricted; 2. Present with mild/moderate facial and neck skin laxity, with FLR (Facial Laxity Rating Scale) rating ranging from grade 2 to 6 for the upper and middle face or the lower face; 3. After fully understanding the treatment plan and risks, the individual voluntarily signs the informed consent form, is willing to participate in the self-controlled trial, and cooperates with follow-up visits.p;
Exclusion criteria
Exclusion criteria: 1.Has a history of severe skin allergies and the subject is currently in an active period of skin allergies; 2.History of skin exposure within the past week (such as sunbathing or outdoor work); 3.Within the past 6 months, the area to be treated has received skin rejuvenation treatments such as botulinum toxin and fat filling; 4.Within the past year, the area to be treated has received unipolar radiofrequency or focused ultrasound therapy, or facial fillers such as sodium hyaluronate, collagen, polylactic acid, hydroxyapatite, etc; 5.Individuals who have undergone facial lifting surgery or other facial plastic surgery in the area to be treated within the past year; 6.Those who plan to undergo major facial surgery or other facial beauty treatments during the research period; 7.Received bipolar or multipole radiofrequency therapy, ablative laser therapy, or other phototherapy such as intense pulsed light on the face within the past 6 months; 8.Those who have undergone or plan to undergo deep chemical exfoliation during the trial period within the past month, or those who have used or plan to use tretinoin or isotretinoin treatment during the trial period within the past month; 9.Have used or plan to use antihistamines, anti-inflammatory and immunosuppressive drugs during the trial period in the past 2 months; 10.Individuals with connective tissue disease or scar constitution; 11.Individuals with autoimmune diseases (such as lupus erythematosus), psoriasis, vitiligo, or those in the active phase of herpes simplex; 12.Patients with serious systemic diseases (such as diabetes, hypertension, etc. that are still uncontrollable after treatment) and serious mental diseases; 13.Subjects with a history of severe heart, liver, kidney dysfunction or malignant tumors; 14.Skin lesions that affect the determination of test results, such as inflammatory reactions, significant scars, vascular tumors, and severe acne, are present in the area to be treated; 15.Patients with cancerous or precancerous lesions in the area to be treated, or those who have received radiation therapy locally; 16.Individuals with systemic or local infections; 17.Individuals with bleeding disorders; 18.Individuals equipped with implantable pacemakers, implantable heart rate defibrillators (ICDs), or any other type of implanted electronic devices; 19.For those with metal implants under the treatment area, such as dental metal implants; 20.Severely obese individuals with BMI>30; History of facial nerve paralysis; Women who are currently pregnant or breastfeeding, or those with fertility plans during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self evaluation of Subject Satisfaction;Adverse event incidence rate;NRS Pain score;3D-VECTRA;VISIA-CR; | — |
Countries
China
Contacts
Public ContactZhang Zhen
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed