Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-05-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Subjects will receive Ulthera® System alone.
Ulthera® System
Focused ultrasound energy delivered below the surface of the skin on the lower face.
Group B
Sculptra® only
Sculptra®
Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
Group C
Sculptra® treatment followed by Ultherapy™ treatment
Sculptra® treatment followed by Ultherapy™ treatment
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Interventions
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Ulthera® System
Focused ultrasound energy delivered below the surface of the skin on the lower face.
Sculptra®
Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
Sculptra® treatment followed by Ultherapy™ treatment
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject in good health.
* Skin laxity in the lower face and neck.
* Grade 1 and 2 on the Knize Scale
Exclusion Criteria
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and neck.
* Excessive skin laxity on the face and neck.
* No scarring in areas to be treated.
* Any open facial wounds or lesions.
* Acne on the face.
* Patients who have a history with keloid formation or hypertropic scarring
* Patients who have a hypersensitivity to injectable poly-L-lactic acid
* Presence of a metal stent or implant in the facial area to be treated.
35 Years
60 Years
ALL
Yes
Sponsors
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Ulthera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Burns, MD
Role: PRINCIPAL_INVESTIGATOR
EpiCentre Park Lane
Locations
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EpiCentre Park Lane
Dallas, Texas, United States
Countries
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Other Identifiers
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ULT-113
Identifier Type: -
Identifier Source: org_study_id
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