Clinical trial NCT01708512: Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Detailed description: This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 25 to 60 years.
* Subject in good health.
* Skin laxity in the area(s) to be treated.
* Understands and accepts the obligation not to undergo any other procedures in the area(s) 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 area(s) to be treated.
* Excessive skin laxity on the area(s) to be treated.
* Significant scarring in area(s) to be treated.
* Open wounds or lesions in the area(s) to be treated.
* Severe or cystic acne on the area(s) to be treated.
* Presence of a metal stent or implant in the area(s) to be treated.
* Inability to understand the protocol or to give informed consent.
* BMI equal to and greater than 30.

Primary outcomes:
measure: Improvement in overall lifting and tightening of the skin
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall aesthetic improvement
timeFrame: 365 days post-treatment
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
name: William P Werschler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Werschler WP, Werschler PS. Long-term Efficacy of Micro-focused Ultrasound with Visualization for Lifting and Tightening Lax Facial and Neck Skin Using a Customized Vectoring Treatment Method. J Clin Aesthet Dermatol. 2016 Feb;9(2):27-33.