Clinical Research Directory

Treatment of Aging Signs of the Skin With Bipolar Radiofrequency

This is a retrospective data collection from patients treated with the bipolar radiofrequency applicator (Coaxipolar) of the Accent devices. Patient files were screened for suitable candidates providing before and after treatment pictures for blinded evaluation. The safety and efficacy of bipolar RF technology, both as a standalone treatment and in combination with unipolar RF, for facial contouring and the reduction of wrinkles and fine lines is investigated.

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial. The main questions the study aims to answer are: Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable? Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement. Participants will: Undergo a single treatment session with either the investigational device or the control device. Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes. The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation. Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.