Feasibility Study: Histological Characterization After Treatment With the Ulthera® System

This study has been terminated.
(Slow subject enrollment; study to be obtained is no longer required.)
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713569
First received: October 22, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Skin Laxity
Device: Ulthera Treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • To determine the depth of focused thermal injury and thermal injury zone dimensions. [ Time Frame: 48 hours post-treatment ] [ Designated as safety issue: Yes ]
    Post‐treatment, treated tissue will be resected for histological analysis.


Enrollment: 2
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
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.
Device: Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713569

Locations
United States, California
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Gordon Sasaki, MD Sasaki Advanced Aesthetic Medical Center
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713569     History of Changes
Other Study ID Numbers: ULT-122
Study First Received: October 22, 2012
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014