Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facial Skin Laxity
- Sponsor
- Ulthera, Inc
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Change in Overall Lifting and Tightening of Treated Tissue
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Change in Overall Lifting and Tightening of Treated Tissue
Time Frame: 90 days post treatment
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
Secondary Outcomes
- Patient Satisfaction Questionnaire(180 days post-treatment)
- Global Aesthetic Improvement at 90 Days Post-treatment(90 Days post-treatment)
- Global Aesthetic Improvement at 180 Days Post-treatment(180 days post-treatment)