Conditions: Skin Laxity
Keywords: Ulthera® System Ultherapy™ treatment Ulthera, Inc. Ultrasound treatment for skin tightening Skin laxity on the face and neck.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: yes

Brief summary:
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Detailed description:
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Arms:
arm 1: Subjects will receive Ulthera® System alone. arm 2: Sculptra® only arm 3: Sculptra® treatment followed by Ultherapy™ treatment

Interventions: intervention 1: Ulthera® System intervention 2: Sculptra® intervention 3: Sculptra® treatment followed by Ultherapy™ treatment
Intervention descriptions: intervention 1: Focused ultrasound energy delivered below the surface of the skin on the lower face. intervention 2: Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart. intervention 3: Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Protocol document: