Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Launched by ULTHERA, INC · Oct 16, 2012

Keywords

ClinConnect Summary

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, aged 25 to 60 years.
• • Subject in good health.
• • Skin laxity in the area(s) to be treated.
• • Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.
• • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• Exclusion Criteria:
• • Presence of an active systemic or local skin disease that may affect wound healing.
• • Severe solar elastosis.
• • Excessive subcutaneous fat in the area(s) to be treated.
• • Excessive skin laxity on the area(s) to be treated.
• • Significant scarring in area(s) to be treated.
• • Open wounds or lesions in the area(s) to be treated.
• • Severe or cystic acne on the area(s) to be treated.
• • Presence of a metal stent or implant in the area(s) to be treated.
• • Inability to understand the protocol or to give informed consent.
• • BMI equal to and greater than 30.