Back to resultsEvaluation of the Ulthera® System for Treatment of the Face and Neck
Primary Purpose
Wrinkles, Rhytids, Skin Laxity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Wrinkles focused on measuring Ultherapy™ treatment, Ulthera® System, Ulthera, Inc., Ultrasound treatment for skin tightening
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 30 to 65 years.
- Subject in good health.
- Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
- Mild to moderate rhytids in the periorbital or perioral region.
- Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
- Mild to moderate vertical perioral lines
- Mild to moderate marionette lines.
- Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheek.
- Excessive skin laxity on the lower face and neck.
- Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
- Excessive hooding with or without redundant skin in the areas to be treated.
Sites / Locations
- Dermatology, Cosmetic & Laser Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulthera® treatment
Arm Description
All enrolled subjects will receive one full face and neck Ulthera® treatment.
Outcomes
Primary Outcome Measures
Improvement in facial wrinkles and lifting and tightening of skin
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
Secondary Outcome Measures
Overall aesthetic improvement
Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
Overall patient satisfaction
Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01713907
Brief Title
Evaluation of the Ulthera® System for Treatment of the Face and Neck
Official Title
Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Inadequate study staff to appropriately manage trial.
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 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
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed Description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkles, Rhytids, Skin Laxity
Keywords
Ultherapy™ treatment, Ulthera® System, Ulthera, Inc., Ultrasound treatment for skin tightening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ulthera® treatment
Arm Type
Experimental
Arm Description
All enrolled subjects will receive one full face and neck Ulthera® treatment.
Intervention Type
Device
Intervention Name(s)
Ulthera® Treatment
Other Intervention Name(s)
Ultherapy™ System, Ulthera, Inc.
Intervention Description
Focused ultrasound energy delivered below the surface of the skin.
Primary Outcome Measure Information:
Title
Improvement in facial wrinkles and lifting and tightening of skin
Description
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Overall aesthetic improvement
Description
Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
Time Frame
Participants will be followed up to 180 days post-treatment
Title
Overall patient satisfaction
Description
Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Time Frame
90 and 180 day post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 30 to 65 years.
Subject in good health.
Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
Mild to moderate rhytids in the periorbital or perioral region.
Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
Mild to moderate vertical perioral lines
Mild to moderate marionette lines.
Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat on the cheek.
Excessive skin laxity on the lower face and neck.
Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
Excessive hooding with or without redundant skin in the areas to be treated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hema Sundaram, MD
Organizational Affiliation
Dermatology, Cosmetic & Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology, Cosmetic & Laser Surgery
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Ulthera® System for Treatment of the Face and Neck
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