Clinical Research Directory

Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

The goal of this clinical study is to evaluate the safety and clinical effectiveness of the XERF noninvasive dual-frequency monopolar radiofrequency device for aesthetic improvement of facial aging, including fine lines and wrinkles, eyebrow lifting, and tightening of lax tissue in the lower face, submental area, and neck in healthy adults. Up to 60 participants may be enrolled across up to five clinical sites in the United States. Participants receive XERF treatments using 6.78 MHz and 2.0 MHz energy; most undergo two sessions approximately four weeks apart (the protocol allows up to three). Standardized photographs are taken at baseline and follow-up visits. Outcomes are assessed approximately 30 and 90 days after the final treatment. Effectiveness is evaluated using investigator-assessed global aesthetic improvement and participant-reported satisfaction, while safety and tolerability are assessed through procedural pain ratings and monitoring of adverse events throughout the study.

Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

The aim of this study is to evaluate the efficacy and safety of intradermal injections of the medical device - hyaluronic acid with the addition of lecithin - in a population of participants with thin, dry, and sagging facial skin.

Focused Ultrasound Treatment for Facial Skin Laxity

The goal of this clinical trial is to learn if focused ultrasound can improve facial skin laxity in adults. The main questions this study aims to answer are: 1. Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments? 2. What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design. Participants will: Receive a single session of focused ultrasound treatment applied to both sides of the face. Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits. Be monitored for treatment-related adverse events throughout the study period.

Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue

This is a prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical study designed to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS, a high-intensity focused ultrasound (HIFU) device, for lifting and tightening lax submental (beneath the chin) and neck tissue in adult subjects. Approximately 273 subjects will be enrolled at multiple investigational sites across the United States. Participants will receive either the ULTRAFORMER MPT PLUS treatment or the predicate comparator device, and will be followed for safety and efficacy assessments including clinical photography, investigator evaluation, and patient-reported outcomes. The study aims to demonstrate that ULTRAFORMER MPT PLUS is non-inferior to the approved reference device in improving skin laxity and wrinkle appearance of the lower face and neck.

Study on the Efficacy and Safety of PLLA Injections for Improving Facial Laxity Following GLP-1 Analog Therapy

Following weight loss with GLP-1 receptor agonists, facial skin laxity and sagging have become another concern for some patients. The temples, cheeks, tear troughs, jawline, marionette lines, and nasolabial folds are the most common areas of volume loss or wrinkles after semaglutide treatment. Restoring facial volume after discontinuing weight-loss medications poses a challenge, as the sole use of hyaluronic acid or permanent fillers may lead to a significant number of patients requiring corrective treatment for overfilled facial syndrome.Poly-L-lactic acid (PLLA) works by releasing low concentrations of lactic acid to stimulate fibroblast-mediated collagen synthesis. Additionally, macrophages participate in the collagen production process triggered by lactic acid, ultimately improving skin laxity. This study aims to evaluate the safety and efficacy of PLLA injections in addressing facial laxity following GLP-1 analogue therapy.