- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519206
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Laser & Skin Surgery Center of NY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultherapy treatment
Ulthera System Treatment
|
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Overall Lifting and Tightening of Skin
Time Frame: Baseline to 90 days post treatment
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Time Frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
|
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
|
Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
|
Subjects' Assessment of Pain
Time Frame: During Ulthera treatment
|
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.
Subjects rated pain for each transducer, in each treatment region.
For statistical analyses, NRS scores were averaged for each transducer depth.
|
During Ulthera treatment
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Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Time Frame: Baseline to 90 days, 180 days and 1 year post-treatment
|
Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment.
Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied.
Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval.
Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
|
Baseline to 90 days, 180 days and 1 year post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roy Geronemus, M.D., Laser & Skin Surgery Center of NY
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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