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 ]

Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.


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:

    1. = Very Much Improved
    2. = Much Improved
    3. = Improved
    4. = No Change
    5. = 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:

    1. = Very Much Improved
    2. = Much Improved
    3. = Improved
    4. = No Change
    5. = 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