Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Ulthera, Inc
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Improvement in facial wrinkles and lifting and tightening of skin
Study Overview
Brief Summary
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed Description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, aged 30 to 65 years.
- •Subject in good health.
- •Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
- •Mild to moderate rhytids in the periorbital or perioral region.
- •Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
- •Mild to moderate vertical perioral lines
- •Mild to moderate marionette lines.
- •Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
- •Understands and accepts the obligation not to undergo any other procedures in the areas 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 on the cheek.
- •Excessive skin laxity on the lower face and neck.
- •Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
- •Excessive hooding with or without redundant skin in the areas to be treated.
Arms & Interventions
Ulthera® treatment
All enrolled subjects will receive one full face and neck Ulthera® treatment.
Intervention: Ulthera® Treatment (Device)
Outcomes
Primary Outcomes
Improvement in facial wrinkles and lifting and tightening of skin
Time Frame: 90 days post-treatment
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
Secondary Outcomes
- Overall patient satisfaction(90 and 180 day post-treatment)
- Overall aesthetic improvement(Participants will be followed up to 180 days post-treatment)