?Skin Aging
Conditions
Interventions
Experimental Group:1. Topical Anesthesia Application: Using a spatula, apply a topical anesthetic cream to one half of the face at a uniform thickness comparable to a 1-yuan coin (approx. 1.9 mm). Cov
Sponsors
Xinjiang Uygur Autonomous Region People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Individuals dissatisfied with their facial appearance or voluntarily seeking treatment for facial laxity. 2.Presentation of mild to moderate facial laxity, as assessed according to the criteria detailed in Appendix II. 3.Age range: 30 to 50 years. 4.Good subject compliance, full understanding of the clinical trial, realistic expectations regarding the aesthetic outcomes of gold micro-needling treatment, and willingness to adhere to the study procedures until its completion. 5.Voluntary provision of written informed consent after fully comprehending the trial requirements. 6.No receipt of other facial anti-aging treatments within the past 6 months and agreement to refrain from undergoing any other facial anti-aging procedures for the duration of the study. 7.Absence of significant left-right facial asymmetry.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe facial skin laxity, as assessed by a facial and neck laxity rating scale. 2. Individuals with unrealistic treatment expectations. 3. Subjects with a Body Mass Index (BMI) >= 30 at screening. 4. Presence of active bacterial, fungal, or viral infections in the treatment area; severe or cystic acne; open wounds; systemic or local dermatitis; a history of keloid formation; or diagnosed autoimmune diseases—where the investigator judges these conditions could affect efficacy evaluation or subject safety. 5. Individuals with implanted electronic devices, such as pacemakers or defibrillators. 6. Any facial rejuvenation procedure (e.g., facelift, soft tissue augmentation, laser resurfacing, skin rejuvenation, intense pulsed light (IPL), radiofrequency (RF) treatments, dermabrasion, chemical peels, or any type of injectable fillers or other ablative/non-ablative procedures) within 6 months prior to screening or planned during the study period. 7. Use of medications that may prolong bleeding time (e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), clopidogrel, warfarin) within 2 weeks prior to screening, or any anticipated need for anticoagulant therapy (including but not limited to warfarin, heparin) during the trial. 8. Use of topical medications on the facial skin (e.g., corticosteroids, retinoic acid ointments) within 4 weeks prior to screening, or anticipated need for such medications on the face or neck during the study (up to 24 weeks after the final treatment). 9. Any planned surgery or medication during the study period that could cause significant weight change (>=10% of body weight) (e.g., systemic corticosteroids, weight-loss drugs, bariatric surgery). 10. Other general exclusions: A. Participation in any other clinical trial within 3 months prior to screening. B. Pregnancy or lactation. C. History or presence of severe cardiovascular, gastrointestinal, respiratory, endocrine, renal, or hepatic diseases; liver dysfunction; malignancy (diagnosed within the past 5 years); or central nervous system/psychiatric disorders that may impair understanding or cooperation—as judged by the investigator. D. Any other comorbid condition deemed by the investigator to potentially interfere with study assessments or pose additional risk to the subject. E. Any other reason considered by the investigator to make the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin Hydration;Skin Glossiness;Transepidermal Water Loss, TEWL;Epidermal Thickness;Dermal Density;VISIA Complexion Analysis System Index;Dermatoscopic Assessment of Pore Improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial Laxity Rating Scale (FLR);Global Aesthetic Improvement Scale (GAIS);Patient Satisfaction;Intraoperative Pain Intensity;Incidence of Adverse Reactions; | — |
Countries
China
Contacts
Public ContactDing yuan
Xinjiang Uygur Autonomous Region People's Hospital
Outcome results
None listed