Rhytids, Skin Laxity, Wrinkles
Conditions
Keywords
Ultherapy™ treatment, Ulthera® System, Ulthera, Inc., Ultrasound treatment for skin tightening
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.
Interventions
DEVICEUlthera® Treatment
Focused ultrasound energy delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in facial wrinkles and lifting and tightening of skin | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall aesthetic improvement | Participants will be followed up to 180 days post-treatment | Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline. |
| Overall patient satisfaction | 90 and 180 day post-treatment | Determined based on Patient Satisfaction and Quality of Life questionnaire scores. |
Countries
United States
Outcome results
None listed