Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
NCT ID: NCT01713569
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2012-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Subject 1
Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 1.2 Joules and 30 Watts on the Left side versus 0.9 Joules and 30 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Subject 2
Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 1.05 Joules and 25 Watts on the Left side versus 0.75 Joules and 25 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Subject 3
Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 0.45 Joules and 15 Watts on the Left side versus 0.35 Joules and 14 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Subject 4
Ulthera treatment will be administered to both pre-auricular regions using a 10 MHz, 1.5mm depth transducer at 0.25 Joules and 5 Watts on the Left side versus 0.18 Joules and 5 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Subject 5
Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus 7 MHz, 4.5mm 0.9 Joules and 25 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Subject 6
Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm transducer at 0.35 and 14 Watts, and a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus a 7 MHz, 3.0mm depth and 4.5mm depth transducer at 2.0 Joules and 40 Watts on the Right side.
Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Interventions
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Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject in good health.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
* 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.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Exclusion Criteria
* Severe solar elastosis.
* 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.
* Presence of a metal stent or implant in the facial area to be treated.
* Inability to understand the protocol or to give informed consent.
30 Years
65 Years
ALL
Yes
Sponsors
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Ulthera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Gordon Sasaki, MD
Role: PRINCIPAL_INVESTIGATOR
Sasaki Advanced Aesthetic Medical Center
Locations
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Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States
Countries
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Other Identifiers
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ULT-122
Identifier Type: -
Identifier Source: org_study_id