A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

• ClinicalTrials.gov Identifier: NCT01519934
• Recruitment Status: Completed
• First Posted: January 27, 2012
• Results First Posted: April 23, 2014
• Last Update Posted: December 18, 2017
• Sponsor: Ulthera, Inc
• Information provided by (Responsible Party): Merz North America, Inc. ( Ulthera, Inc )

Study Description

Brief Summary:

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 or disease
Skin Laxity; Wrinkles

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 Design

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck
• Study Start Date: October 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: August 2012

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Improvement in Overall Lifting and Tightening of the Skin [ Time Frame: Baseline to 180 days post-treatment ]
   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 :

1. Overall Aesthetic Improvement [ Time Frame: Baseline to 180 days post-treatment ]

   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
2. Subject Perception of Age [ Time Frame: Baseline to 180 days post-treatment ]
   Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.
3. Patient Satisfaction [ Time Frame: 180 days post-treatment ]
   Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ulthera, Inc
• ClinicalTrials.gov Identifier: NCT01519934
• Other Study ID Numbers: ULT-120
• First Posted: January 27, 2012
• Results First Posted: April 23, 2014
• Last Update Posted: December 18, 2017
• Last Verified: November 2017

Keywords provided by Merz North America, Inc. ( 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