Skin Laxity
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 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 skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
Interventions
DEVICEUlthera System 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
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, age 21 to 65 years. * Subject in good health. * Mild to moderate skin laxity on the elbows. * 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. * Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Excessive subcutaneous fat around the elbows. * Excessive skin laxity around the elbows. * Significant scarring in areas to be treated. * Significant open wounds or lesions in the area to be treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall improvement of skin laxity in the areas treated | 90 days post-treatment | Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic improvement | 90 and 180 days post-treatment | GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained. |
Countries
United States
Outcome results
None listed