Acne vulgaris
Conditions
Interventions
Single Group:Intervention Device: YOUMAGIC Monopolar Radiofrequency Skin Treatment Device (NMPA Registration No.: 20243092361, Manufacturer: Wuxi Weimaitong Medical Technology Co., Ltd.).
Treatment Fr
Sponsors
Department of Plastic Surgery & Cosmetic Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-50 years, regardless of gender; 2.With mild to moderate facial and neck skin laxity, where the Facial Laxity Rating Scale (FLR) grade for the upper-middle face or lower face is 1-6 , and at the same time, the Investigator Global Assessment (IGA) meets the diagnostic criteria for moderate to severe acne (grade 2-4); 3.Subjects voluntarily participate in this study, comply with the researcher's arrangement for hospital visits for treatment and examinations, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Having a history of severe skin allergies and being in the active phase of skin allergies; 2.Having experienced skin exposure to intense sunlight (e.g., sunbathing, outdoor workers, etc.) within the past 1 week; 3.Having received skin anti-wrinkle treatments such as botulinum toxin injection or fat injection in the treatment area within the past 6 months; 4.Having received monopolar radiofrequency or ultrasound treatment, or injections of hyaluronic acid, polylactic acid, or polycaprolactone (PCL) facial fillers in the treatment area within the past 1 year; 5.Having received facial lifting surgery or other facial plastic surgery in the treatment area within the past 1 year; 6.Planning to undergo major facial surgery or other facial medical aesthetic treatments during the study period; 7.Having received bipolar/multipolar radiofrequency treatment or ablative laser treatment within the past 6 months, or facial intense pulsed light (IPL) treatment or other photoelectric treatments within the past 1 month; 8.Having received deep chemical peeling within the past 1 month or planning to undergo it during the trial period; or having used retinoic acid or isotretinoin within the past 1 month or planning to use them during the trial period; 9.Having used antihistamines, anti-inflammatory drugs, or immunosuppressants within the past 1 month or planning to use them during the trial period; 10.Suffering from connective tissue diseases or having a scar constitution; 11.Suffering from autoimmune diseases (e.g., lupus erythematosus), psoriasis, vitiligo, or being in the active phase of herpes simplex; 12.Complicated with severe systemic diseases (e.g., uncontrolled diabetes, hypertension after treatment), or severe mental illnesses; 13.Having a history of severe heart, liver, or kidney dysfunction, or malignant tumors; 14.Having skin lesions such as hemangiomas in the treatment area that may affect the judgment of trial results; 15.Having cancer, precancerous lesions in the treatment area, or having received local radiotherapy; 16.Suffering from hemorrhagic diseases; 17.Having implanted electronic devices such as a pacemaker, implantable cardioverter-defibrillator (ICD), or any other type of implanted electronic device; 18.Having metal implants under the treatment area (e.g., dental metal implants); 19.Having a history of facial nerve palsy; 20.Being pregnant or lactating women, or having plans for pregnancy during the study period; 21.Subjects assessed by researchers as unsuitable for participating in this clinical study due to poor compliance, perceptual impairment, or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale (GAIS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator Global Assessment (IGA);Global Acne Grading System (GAGS);Acne Lesion Count;Sebum Secretion Level;Skin Elasticity;5-Point Global Assessment Scale (GAS);Numerical Rating Scale (NRS); | — |
Countries
China
Contacts
Public ContactChen Lujia
Department of Plastic Surgery & Cosmetic Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Outcome results
None listed