Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Laxity
- Sponsor
- Ulthera, Inc
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Improvement in lower face and neck skin laxity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age 30 to 65 years.
- •Subject in good health.
- •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
Outcomes
Primary Outcomes
Improvement in lower face and neck skin laxity
Time Frame: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline
Cervicomental angle
Time Frame: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline.
Secondary Outcomes
- Patient satisfaction(90 days post-treatment)
- Pain Assessment(Treatment visit)
- Patient Satisfaction(180 days post-treatment)
- Overall aesthetic improvement(180 days post-treatment)