A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01519934
First received: November 7, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition
Skin Laxity
Wrinkles

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in Overall Lifting and Tightening of the Skin [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Aesthetic Improvement [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]

    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:

    1. = Very Much Improved
    2. = Much Improved
    3. = Improved
    4. = No Change
    5. = Worse

  • Subject Perception of Age [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]
    Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.

  • Patient Satisfaction [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.


Enrollment: 48
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ulthera-treated subjects
All enrolled subjects will have received an Ulthera treatment prior to enrollment.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  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: NCT01519934

Locations
United States, California
Dermatology Cosmetic Laser Associates
San Diego, California, United States, 92121
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Mitchel Goldman, MD Dermatology Cosmetic Laser Associates
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01519934     History of Changes
Other Study ID Numbers: ULT-120
Study First Received: November 7, 2011
Results First Received: December 30, 2013
Last Updated: March 19, 2014
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 July 28, 2014