Who is sponsoring NCT02416076?

NCT02416076 is sponsored by Ulthera, Inc.

What condition does NCT02416076 study?

NCT02416076 studies Skin Laxity.

What drugs are being tested in NCT02416076?

Interventions: Ulthera Treatment at EL2, Ulthera Treatment at EL4.

What is the status of NCT02416076?

NCT02416076 is currently COMPLETED.

Last reviewed 2019-04-16 · How we verify

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

NCT02416076 NA COMPLETED

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.

Details

Lead sponsor	Ulthera, Inc
Phase	NA
Status	COMPLETED
Enrolment	42
Start date	2014-12-15
Completion	2016-01

Conditions

Skin Laxity

Interventions

Ulthera Treatment at EL2
Ulthera Treatment at EL4

Primary outcomes

Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment — During study treatment. Participants will be followed for an average of 90 minutes.
Subjects' treatment-related pain scores will be obtained using a validated 0-10 point Numeric Rating Scale while study treatment is being administered. It is estimated that each study treatment will be completed in approximately 90 minutes.

Countries

United States