Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Ulthera

Status

Completed

Conditions

Facial Skin Laxity

Treatments

Device: Ulthera® System treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01368965

ULT-112

Details and patient eligibility

About

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

Full description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Enrollment

54 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 30 to 65 years.
Subject in good health.
Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
Fitzpatrick skin phototypes of 3 through 6.
Provide written informed consent and HIPAA authorization

Exclusion criteria

Pregnant or lactating.
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat on the cheek.
Excessive skin laxity on the lower face and neck.
Significant scarring in areas to be treated.
Significant open facial wounds or lesions.
Severe or cystic acne on the face.
Presence of a metal stent or implant in the facial area to be treated.