Skin Crepiness, Skin Laxity
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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 for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, 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
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 25 to 60 years. * Subject in good health. * Skin laxity in the abdomen * 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 in the abdomen. * Excessive skin laxity on the abdomen. * Significant scarring in areas to be treated. * Open wounds or lesions in the area to be treated. * Inability to understand the protocol or to give informed consent. * BMI equal to and greater than 30.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement laxity/crepiness and texture of abdominal tissue | 90 days post-treatment | Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall aesthetic improvement | 180 days post-treatment | The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos. |
Countries
United States
Outcome results
None listed