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Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

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

NCT01708512•Ulthera, Inc

View on ClinicalTrials.gov

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

Age

25 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Premier Clinical Research

Spokane, Washington, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

December 1, 2012

Completion Date

July 1, 2013

Last Updated

November 24, 2017

Enrollment

ACTUAL participants

Conditions

Skin Laxity

Interventions

Ulthera System Treatment

DEVICE

An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

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Skin Laxity

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NOT_YET_RECRUITINGNA

Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Inclusion Criteria

Exclusion Criteria

An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery

Device for Improving Skin Quality and Texture on the Face and Neck

Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin