Skin Laxity
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Detailed description
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will 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
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, age 30 to 65 years. * Subject in good health. * BMI \< 30. * Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle * Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107). * Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
Exclusion criteria
* Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control. * Presence of an active systemic or local skin disease that may affect wound healing. * Severe solar elastosis. * Excessive subcutaneous fat on the cheeks. * Excessive skin laxity on the lower face and neck * Significant scarring in areas to be treated. * Open wounds or lesions in the area to be treated. * Severe or cystic acne on the area to be treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in lower face and neck skin laxity | 90 days post-treatment | Efficacy will be assessed using the 90-day images compared to baseline |
| Cervicomental angle | 90 days post-treatment | Efficacy will be assessed using the 90-day images compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall aesthetic improvement | 90 days post-treatment | Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment. |
| Patient satisfaction | 90 days post-treatment | Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment. |
| Pain Assessment | Treatment visit | Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment. |
| Patient Satisfaction | 180 days post-treatment | Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment. |
Countries
United States
Outcome results
None listed