Back to resultsFeasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
Primary Purpose
Skin Laxity, Wrinkles
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera System Treatment
Thermage
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, age 30 to 65 years.
- Subject in good health.
- Skin laxity on the area(s) to be treated.
- 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 in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated.
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne on the area(s) to be treated.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
- Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- BMI equal to or greater than 25.
Sites / Locations
- FACES+
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Ulthera System Treatment Right, Thermage Left
Ulthera System Treatment Left, Thermage Right
Outcomes
Primary Outcome Measures
Number of Participants with Lifting and Tightening of Skin
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Number of Participants with Wrinkle Reduction
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
Secondary Outcome Measures
Number of Participants with Eyebrow Lift
Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.
Number of Participants with Lower face and Neck Lift
Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
Number of Participants Reporting Treatment Satisfaction
Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01713985
Brief Title
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
Official Title
Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (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 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 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, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. 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, Wrinkles
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Ulthera System Treatment Right, Thermage Left
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Ulthera System Treatment Left, Thermage Right
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
Intervention Type
Device
Intervention Name(s)
Thermage
Intervention Description
Radiofrequency treatment focusing radiofrequency energy
Primary Outcome Measure Information:
Title
Number of Participants with Lifting and Tightening of Skin
Description
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Time Frame
180 days post treatment
Title
Number of Participants with Wrinkle Reduction
Description
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
Time Frame
180 days post treatment
Secondary Outcome Measure Information:
Title
Number of Participants with Eyebrow Lift
Description
Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.
Time Frame
90 days post-treatment
Title
Number of Participants with Lower face and Neck Lift
Description
Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
Time Frame
90 days post-treatment
Title
Number of Participants Reporting Treatment Satisfaction
Description
Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.
Time Frame
180 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, age 30 to 65 years.
Subject in good health.
Skin laxity on the area(s) to be treated.
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 in the area(s) to be treated.
Excessive skin laxity on the area(s) to be treated.
Significant scarring in the area(s) to be treated.
Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Presence of a metal stent or implant in the area(s) to be treated.
Inability to understand the protocol or to give informed consent.
Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
BMI equal to or greater than 25.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Cohen, MD
Organizational Affiliation
Faces+
Official's Role
Principal Investigator
Facility Information:
Facility Name
FACES+
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
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