A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Completed

• Conditions: Wrinkles; Skin Laxity

• Registration Number: NCT01519934
• Lead Sponsor: Ulthera, Inc

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Results First Submitted: 2013-12-30
• Results First Submitted QC: 2014-03-19
• Results First Posted: 2014-04-23
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Overall Lifting and Tightening of the Skin	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

Name	Time	Method
Subject Perception of Age	Baseline to 180 days post-treatment	Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.
Patient Satisfaction	180 days post-treatment	Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.
Overall Aesthetic Improvement	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

Trial Locations

Locations (1)

Dermatology Cosmetic Laser Associates; 🇺🇸 San Diego, California, United States