A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Skin Laxity Clinical Trial

Official title:

Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519934
• Other study ID #: ULT-120
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: November 10, 2017
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2017
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity
• Wrinkles

Locations

Country	Name	City	State
United States	Dermatology Cosmetic Laser Associates	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Overall Lifting and Tightening of the Skin	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.	Baseline to 180 days post-treatment
Secondary	Overall Aesthetic Improvement	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: = Very Much Improved; = Much Improved; = Improved; = No Change; = Worse	Baseline to 180 days post-treatment
Secondary	Subject Perception of Age	Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.	Baseline to 180 days post-treatment
Secondary	Patient Satisfaction	Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.	180 days post-treatment