Feasibility Study: Lifting and Tightening Neck Skin in Patients
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera System 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
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 30 to 65 years
- Subject in good health
- Body Mass index of less than 30
- Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
- Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
- 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
- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control
Exclusion Criteria:
- Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
- Has an active systemic or local skin disease that may alter wound healing
- Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
- Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
Sites / Locations
- DeNova Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Subjects who have previous history of submentoplasty and or rhytidectomy
Subjects naïve to submentoplasty and or rhytidectomy
Outcomes
Primary Outcome Measures
Change in submental volume
Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
Secondary Outcome Measures
Overall improvement of the submental area
Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708928
Brief Title
Feasibility Study: Lifting and Tightening Neck Skin in Patients
Official Title
Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 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 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.
Detailed Description
This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Subjects who have previous history of submentoplasty and or rhytidectomy
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects naïve to submentoplasty and or rhytidectomy
Intervention Type
Device
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Primary Outcome Measure Information:
Title
Change in submental volume
Description
Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Overall improvement of the submental area
Description
Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.
Time Frame
90 days 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
Body Mass index of less than 30
Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
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
Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control
Exclusion Criteria:
Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
Has an active systemic or local skin disease that may alter wound healing
Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Dayan, MD
Organizational Affiliation
DeNova Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Lifting and Tightening Neck Skin in Patients
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