Back to resultsUltherapy™ Treatment Following Sculptra® Treatment
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System
Sculptra®
Sculptra® treatment followed by Ultherapy™ treatment
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.
Eligibility 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.
Sites / Locations
- EpiCentre Park Lane
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Subjects will receive Ulthera® System alone.
Sculptra® only
Sculptra® treatment followed by Ultherapy™ treatment
Outcomes
Primary Outcome Measures
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01422538
Brief Title
Ultherapy™ Treatment Following Sculptra® Treatment
Official Title
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Subjects will receive Ulthera® System alone.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Sculptra® only
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Sculptra® treatment followed by Ultherapy™ treatment
Intervention Type
Device
Intervention Name(s)
Ulthera® System
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin on the lower face.
Intervention Type
Drug
Intervention Name(s)
Sculptra®
Other Intervention Name(s)
Poly-L-Lactic acid fillers
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sculptra® treatment followed by Ultherapy™ treatment
Intervention Description
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Primary Outcome Measure Information:
Title
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
Description
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.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Overall Aesthetic Improvement at 90 Days Post-treatment
Description
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.
Time Frame
90 days post-treatment.
Title
Overall Aesthetic Improvement at 180 Days Post-treatment
Description
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.
Time Frame
180 days post-treatment
Title
Subject Satisfaction at 90 Days Post-treatment
Description
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.
Time Frame
90 days post-treatment.
Title
Subject Satisfaction at 180 Days Post-treatment
Description
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.
Time Frame
180 days post-treatment
Other Pre-specified Outcome Measures:
Title
Subject's Assessment of Pain
Description
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.
Time Frame
During Ulthera study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Burns, MD
Organizational Affiliation
EpiCentre Park Lane
Official's Role
Principal Investigator
Facility Information:
Facility Name
EpiCentre Park Lane
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ultherapy™ Treatment Following Sculptra® Treatment
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