Ultherapy™ Treatment Following Sculptra® Treatment

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

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

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.

Inclusion Criteria:

• Male or female, aged 35 to 60 years.
• Subject in good health.
• Skin laxity in the lower face and neck.
• Grade 1 and 2 on the Knize Scale

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face and neck.
• Excessive skin laxity on the face and neck.
• No scarring in areas to be treated.
• Any open facial wounds or lesions.
• Acne on the face.
• Patients who have a history with keloid formation or hypertropic scarring
• Patients who have a hypersensitivity to injectable poly-L-lactic acid
• Presence of a metal stent or implant in the facial area to be treated.