Back to resultsFeasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
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, age 30 to 65 years.
- Subject in good health.
- BMI < 30.
- Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
- Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
Exclusion Criteria:
- Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
- 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.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated
Sites / Locations
- DeNova Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulthera treatment group
Arm Description
All subjects will receive an Ulthera System Treatment
Outcomes
Primary Outcome Measures
Improvement in lower face and neck skin laxity
Efficacy will be assessed using the 90-day images compared to baseline
Cervicomental angle
Efficacy will be assessed using the 90-day images compared to baseline.
Secondary Outcome Measures
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
Patient satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Pain Assessment
Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Patient Satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708252
Brief Title
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 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 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Detailed Description
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ulthera treatment group
Arm Type
Experimental
Arm Description
All subjects will receive an Ulthera System Treatment
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
Improvement in lower face and neck skin laxity
Description
Efficacy will be assessed using the 90-day images compared to baseline
Time Frame
90 days post-treatment
Title
Cervicomental angle
Description
Efficacy will be assessed using the 90-day images compared to baseline.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Overall aesthetic improvement
Description
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
Time Frame
90 days post-treatment
Title
Patient satisfaction
Description
Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Time Frame
90 days post-treatment
Title
Pain Assessment
Description
Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Time Frame
Treatment visit
Title
Patient Satisfaction
Description
Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Time Frame
180 days post-treatment
Title
Overall aesthetic improvement
Description
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
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.
BMI < 30.
Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
Exclusion Criteria:
Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
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.
Open wounds or lesions in the area to be treated.
Severe or cystic acne on the area to be treated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven H Dayan, MD, FACS
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: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
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