Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 2, 2014
CompletedDecember 11, 2017
November 1, 2017
6 months
December 8, 2011
March 20, 2014
November 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Overall Lifting and Tightening of Skin
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
Baseline to 90 days post treatment
Secondary Outcomes (3)
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
Subjects' Assessment of Pain
During Ulthera treatment
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Baseline to 90 days, 180 days and 1 year post-treatment
Study Arms (1)
Ultherapy treatment
EXPERIMENTALUlthera System Treatment
Interventions
Focused ultrasound energy delivered below the surface of the skin.
Eligibility Criteria
You may qualify if:
- Male or female, aged 30 to 65 years
- Subject in good health
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of 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 followup period
You may not qualify if:
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated
- Significant open facial wounds or lesions
- Severe or cystic acne on the face
- Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulthera, Inclead
Study Sites (1)
Laser & Skin Surgery Center of NY
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
3-D digital imaging was not completed, thus quantitative measure of submental skin lift was not obtained.
Results Point of Contact
- Title
- Public Disclosure Manager
- Organization
- Merz Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Geronemus, M.D.
Laser & Skin Surgery Center of NY
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
January 26, 2012
Study Start
August 1, 2011
Primary Completion
February 1, 2012
Study Completion
March 1, 2013
Last Updated
December 11, 2017
Results First Posted
June 2, 2014
Record last verified: 2017-11