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The purpose of this clinical study is to determine the effectiveness of the Erchonia® GVS in improving the appearance of skin laxity on the abdominal region.
This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.
Upper inner arms of enrolled subjects will be randomized to two (2) treatment groups: Sofwave and Ultherapy, with subjects receiving treatment with one device on their right side and the other on their left.
Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. This study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera) and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).
The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.
The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment. Part 1 Pre-Clinical Study Procedure: * 1 healthy adult (male or female) * 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited. * Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery. * On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure. Part 2 Clinical Study Procedure: * 1 healthy adult (male or female) * 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited. * Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery. * The study team will utilize the specific setting based off the results of Part 1. * Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure. * At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team. * On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.
The goal of this prospective, single-arm clinical study is to gather quantifiable data on Renuvion's impact on skin elasticity and hydration, indicators of skin quality and estimate the biological skin age using DNA methylation in males and females between 18 and 75 years of age who plan to receive a lower facelift surgery. The main purpose is to quantify the effect of the Renuvion device on skin elasticity (collagen density, elastin, fibrillin-1), hydration (aquaporin-3, acidic glycosaminoglycans, HA), and DNA methylation to estimate the biological age of the skin. Participants will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.