Back to resultsFeasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Primary Purpose
Skin Laxity of the décolleté
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity of the décolleté focused on measuring Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Eligibility Criteria
Inclusion Criteria:
- Female, aged 35 to 60 years.
- Subject in good health.
- Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
- 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.
- Scarring in areas to be treated.
- Tattoos in the areas to be treated.
- Patients with ports or defibrillators.
- Breast size >400cc each as measured by water displacement method.
- History of breast reduction surgery.
- Any open wounds or lesions in the area.
- Active and severe inflammatory acne in the region to be treated.
- Patients who have a history with keloid formation or hypertropic scarring
Sites / Locations
- Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultherapy™ treatment on the décolleté
Arm Description
All enrolled subjects will receive the study treatment.
Outcomes
Primary Outcome Measures
Improvement in overall lifting and tightening of skin
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
Secondary Outcome Measures
Skin Laxity of the Décolleté
The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.
Bilateral chest measurements
Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.
Overall aesthetic improvement
Based on Global Aesthetic Improvement Scale (GAIS) scores.
Patient satisfaction
Subject-completed questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01485107
Brief Title
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 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 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
Detailed Description
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity of the décolleté
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
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultherapy™ treatment on the décolleté
Arm Type
Experimental
Arm Description
All enrolled subjects will receive the study treatment.
Intervention Type
Device
Intervention Name(s)
Ulthera® System
Other Intervention Name(s)
Ultherapy™ treatment
Intervention Description
Focused ultrasound energy delivered below the surface of the skin.
Primary Outcome Measure Information:
Title
Improvement in overall lifting and tightening of skin
Description
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Skin Laxity of the Décolleté
Description
The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.
Time Frame
90 and 180 days post-treatment
Title
Bilateral chest measurements
Description
Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.
Time Frame
90 and 180 days post-treatment
Title
Overall aesthetic improvement
Description
Based on Global Aesthetic Improvement Scale (GAIS) scores.
Time Frame
90 and 180 days post-treatment
Title
Patient satisfaction
Description
Subject-completed questionnaire.
Time Frame
90 and 180 days post-treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female, aged 35 to 60 years.
Subject in good health.
Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
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.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Breast size >400cc each as measured by water displacement method.
History of breast reduction surgery.
Any open wounds or lesions in the area.
Active and severe inflammatory acne in the region to be treated.
Patients who have a history with keloid formation or hypertropic scarring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goldman, MD
Organizational Affiliation
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
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 the Ulthera® System for Treatment of the Décolleté
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