A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck

Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Study Overview

• Status: Completed
• Conditions: Wrinkles; Skin Laxity

Detailed Description

This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Dermatology Cosmetic Laser Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of males and females from the investigator's practice between 25 and 85 years of age, who have received an Ultherapy™ treatment on or prior to October 1, 2011, who had pre-treatment baseline photographs taken, and who have chosen to participate in this clinical trial.

Description

Inclusion Criteria:

• Male or female, age 25-85 years.
• Subject in good health.
• Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
• Absence of physical or psychological conditions unacceptable to the investigator.

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Significant scarring in areas treated.
• Open wounds or lesions in the areas treated.
• Severe or cystic acne on the areas treated.
• Inability to understand the protocol or to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ulthera-treated subjects; All enrolled subjects will have received an Ulthera treatment prior to enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Overall Lifting and Tightening of the Skin	Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.	Baseline to 180 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Aesthetic Improvement	Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved; = Much Improved; = Improved; = No Change; = Worse	Baseline to 180 days post-treatment
Subject Perception of Age	Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.	Baseline to 180 days post-treatment
Patient Satisfaction	Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.	180 days post-treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Mitchel Goldman, MD, Dermatology Cosmetic Laser Associates

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: ULT-120