Skin Laxity of the décolleté
Conditions
Keywords
Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
Detailed description
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
Interventions
DEVICEUlthera® System
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
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, aged 35 to 60 years. * Subject in good health. * Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté. * 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. * Scarring in areas to be treated. * Tattoos in the areas to be treated. * Patients with ports or defibrillators. * Breast size \>400cc each as measured by water displacement method. * History of breast reduction surgery. * Any open wounds or lesions in the area. * Active and severe inflammatory acne in the region to be treated. * Patients who have a history with keloid formation or hypertropic scarring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in overall lifting and tightening of skin | 90 days post-treatment | Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral chest measurements | 90 and 180 days post-treatment | Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin. |
| Skin Laxity of the Décolleté | 90 and 180 days post-treatment | The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline. |
| Overall aesthetic improvement | 90 and 180 days post-treatment | Based on Global Aesthetic Improvement Scale (GAIS) scores. |
| Patient satisfaction | 90 and 180 days post-treatment | Subject-completed questionnaire. |
Countries
United States
Outcome results
None listed