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
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

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 21, 2014