Ultherapy™ Treatment Following Sculptra® Treatment

November 16, 2017 updated by: Ulthera, Inc

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • EpiCentre Park Lane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 35 to 60 years.
  • Subject in good health.
  • Skin laxity in the lower face and neck.
  • Grade 1 and 2 on the Knize Scale

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the face and neck.
  • Excessive skin laxity on the face and neck.
  • No scarring in areas to be treated.
  • Any open facial wounds or lesions.
  • Acne on the face.
  • Patients who have a history with keloid formation or hypertropic scarring
  • Patients who have a hypersensitivity to injectable poly-L-lactic acid
  • Presence of a metal stent or implant in the facial area to be treated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Subjects will receive Ulthera® System alone.
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin on the lower face.
Other Names:
  • Ultherapy™
Active Comparator: Group B
Sculptra® only
Drug: Sculptra®
Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
Other Names:
  • Poly-L-Lactic acid fillers
Active Comparator: Group C
Sculptra® treatment followed by Ultherapy™ treatment
Other: Sculptra® treatment followed by Ultherapy™ treatment
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-treatment.
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.
180 days post-treatment
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.
90 days post-treatment.
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.
180 days post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's Assessment of Pain
Time Frame: During Ulthera study treatment
Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.
During Ulthera study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Investigators

  • Principal Investigator: Jay Burns, MD, EpiCentre Park Lane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 24, 2011

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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