Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Ulthera System Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulthera treatment group; All subjects will receive an Ulthera System Treatment	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ultherapy™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in lower face and neck skin laxity	Efficacy will be assessed using the 90-day images compared to baseline	90 days post-treatment
Cervicomental angle	Efficacy will be assessed using the 90-day images compared to baseline.	90 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall aesthetic improvement	Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.	90 days post-treatment
Patient satisfaction	Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.	90 days post-treatment
Pain Assessment	Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.	Treatment visit
Patient Satisfaction	Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.	180 days post-treatment
Overall aesthetic improvement	Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.	180 days post-treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Steven H Dayan, MD, FACS, DeNova Research

Study record dates

Study Major Dates

• Study Start: September 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: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: June 1, 2013

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-127