Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedNovember 24, 2017
June 1, 2013
7 months
December 1, 2011
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 days post-treatment
Secondary Outcomes (4)
Skin Laxity of the Décolleté
90 and 180 days post-treatment
Bilateral chest measurements
90 and 180 days post-treatment
Overall aesthetic improvement
90 and 180 days post-treatment
Patient satisfaction
90 and 180 days post-treatment
Study Arms (1)
Ultherapy™ treatment on the décolleté
EXPERIMENTALAll enrolled subjects will receive the study treatment.
Interventions
Focused ultrasound energy delivered below the surface of the skin.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulthera, Inclead
Study Sites (1)
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
San Diego, California, 92121, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Goldman, MD
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
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 1, 2011
First Posted
December 5, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
May 1, 2012
Last Updated
November 24, 2017
Record last verified: 2013-06