Clinical Trials Logo
  1. Home
  2. Skin Laxity
  3. NCT02416076

Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

Skin Laxity Clinical Trial

Official title:
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Using Standard Transducers Versus Simulines Transducers

Clinical Trial Summary

Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Clinical Trial Description

This is a prospective, multi-center, split-face, randomized pilot trial to determine the clinical feasibility of the Ulthera System prototype simulines transducers, that is, transducers which deliver two lines of treatment simultaneously (at once), in comparison to the standard transducers which deliver a single treatment line, by collecting average pain scores in the treated regions, as well as efficacy and treatment efficiency data. There will be 3 study arms with each arm having 2 treatment groups. Enrolled participants will be randomized to one of two study arms, and one of two treatment groups within each study arm.to determine which side of the face will be treated with Ulthera System standard transducers and Ulthera System prototype simulines transducers and the energy level for treatment. Participants will receive one dual-depth treatment at 4.5 millimeter (mm) and 3.0mm depths.

Clinical feasibility will be assessed based on comfort level of standard transducers versus simulines transducers by comparing average pain scores obtained during study treatment. Efficacy will be determined based on qualitative masked assessment of post-treatment photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements. Patient satisfaction questionnaires will be obtained. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02416076
Study type Interventional
Source Merz North America, Inc.
Contact
Status Completed
Phase N/A
Start date December 15, 2014
Completion date January 2016
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Completed NCT01971736 - Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening N/A
Completed NCT01713985 - Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck N/A
Completed NCT01708382 - Feasibility Study: Lifting and Tightening of the Elbows N/A
Completed NCT01713998 - Treatment of the Face and Neck With Lower Ulthera System Energy Settings N/A
Completed NCT01708252 - Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment N/A
Completed NCT04296201 - Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology N/A
Completed NCT06000839 - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Completed NCT05929625 - Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation N/A
Terminated NCT01713569 - Feasibility Study: Histological Characterization After Treatment With the Ulthera® System N/A
Completed NCT01519934 - A Retrospective Study to Evaluate the Effectiveness of the Ulthera System N/A
Completed NCT05605691 - Post-Market Lower Eyelid Treatment With Renuvion in Greece N/A
Completed NCT04477187 - Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling N/A
Completed NCT05590364 - Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands N/A
Active, not recruiting NCT06243744 - Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery N/A
Completed NCT04146584 - Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow Phase 2
Recruiting NCT05750901 - Evaluation of Fractional Ablative Laser Treatment for Skin Conditions N/A
Completed NCT04721600 - Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance N/A
Recruiting NCT06157567 - Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System N/A