- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713569
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
November 22, 2017 updated by: Ulthera, Inc
Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System
Up to 6 subjects will be enrolled.
Subjects who have already chosen to have a surgical facelift procedure will be enrolled.
Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions.
Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy.
Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.
Study Overview
Detailed Description
This study is a prospective, single-center clinical trial.
Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent.
Enrolled subjects will be treated with an assigned transducer based on their order of enrollment.
At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Sasaki Advanced Aesthetic Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, age 30 to 65 years scheduled for rhytidectomy.
- 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:
- Presence of an active systemic or local skin disease that may affect wound healing.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
ACTIVE_COMPARATOR: 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.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the depth of focused thermal injury and thermal injury zone dimensions.
Time Frame: 48 hours post-treatment
|
Post-treatment, treated tissue will be resected for histological analysis.
|
48 hours post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 22, 2012
First Posted (ESTIMATE)
October 24, 2012
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 22, 2017
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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