A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
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|ClinicalTrials.gov Identifier: NCT01519934|
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 23, 2014
Last Update Posted : December 18, 2017
|Condition or disease|
|Skin Laxity Wrinkles|
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|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|
All enrolled subjects will have received an Ulthera treatment prior to enrollment.
- 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.
- 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:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse
- 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.
- Patient Satisfaction [ Time Frame: 180 days post-treatment ]Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519934
|United States, California|
|Dermatology Cosmetic Laser Associates|
|San Diego, California, United States, 92121|
|Principal Investigator:||Mitchel Goldman, MD||Dermatology Cosmetic Laser Associates|