Clinical Trial: Ultherapy™ Treatment Following Sculptra® Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
Brief Summary: This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Detailed Summary: This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.
Sponsor: Ulthera, Inc
Current Primary Outcome: Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. [ Time Frame: 90 days post-treatment ]
Original Primary Outcome: Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. [ Time Frame: 90 days post-treatment ]
Current Secondary Outcome:
- Overall Aesthetic Improvement at 90 Days Post-treatment [ Time Frame: 90 days post-treatment. ]
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse "Any Improvement" includes subjects assessed in categories 1-3.
- Overall Aesthetic Improvement at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ]
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse "Any Improvement" includes subjects assessed in categories 1-3.
- Subject Satisfaction at 90 Days Post-treatment [ Time Frame: 90 days post-treatment. ]Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.
- Subject Satisfaction at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ]Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.
Original Secondary Outcome:
- Overall improvement in skin laxity. [ Time Frame: 90 and 180 days post-treatment. ]
- Overall aesthetic improvement based on GAIS scores. [ Time Frame: 90 and 180 days post-treatment. ]
- Patient satisfaction. [ Time Frame: 90 and 180 days post-treatment. ]
Information By: Ulthera, Inc
Dates:
Date Received: August 22, 2011
Date Started: May 2011
Date Completion:
Last Updated: June 19, 2013
Last Verified: June 2013