Ultherapy™ Treatment Following Sculptra® Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01422538
First received: August 22, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Skin Laxity
Device: Ulthera® System
Drug: Sculptra®
Other: Sculptra® treatment followed by Ultherapy™ treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Overall Aesthetic Improvement at 90 Days Post-treatment [ Time Frame: 90 days post-treatment. ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Subject's Assessment of Pain [ Time Frame: During Ulthera study treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422538

Locations
United States, Texas
EpiCentre Park Lane
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Jay Burns, MD EpiCentre Park Lane
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01422538     History of Changes
Other Study ID Numbers: ULT-113
Study First Received: August 22, 2011
Results First Received: June 19, 2013
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Skin laxity on the face and neck.

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014