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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708252
First received: November 7, 2011
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Skin Laxity
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in lower face and neck skin laxity [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Efficacy will be assessed using the 90-day images compared to baseline

  • Cervicomental angle [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Efficacy will be assessed using the 90-day images compared to baseline.


Secondary Outcome Measures:
  • Overall aesthetic improvement [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.

  • Patient satisfaction [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.

  • Pain Assessment [ Time Frame: Treatment visit ] [ Designated as safety issue: Yes ]
    Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.

  • Patient Satisfaction [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.

  • Overall aesthetic improvement [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.


Enrollment: 4
Study Start Date: September 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ultherapy™

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708252

Locations
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Steven H Dayan, MD, FACS DeNova Research
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708252     History of Changes
Other Study ID Numbers: ULT-127
Study First Received: November 7, 2011
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

ClinicalTrials.gov processed this record on October 23, 2014