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Treatment of the Face and Neck With Lower Ulthera System Energy Settings

NCT ID: NCT01713998

Last Updated: 2017-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

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This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Conditions

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Skin Laxity

Keywords

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Ulthera® System Ultherapy™ Treatment Ulthera, Inc. Ultrasound treatment for skin tightening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Group B

Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Group C

Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Interventions

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Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity on the face and neck

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face or neck.
* Excessive skin laxity on the face or neck.
* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven H Gitt, MD

Role: PRINCIPAL_INVESTIGATOR

Ulthera, Inc

Locations

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Ulthera, Inc.

Mesa, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-300

Identifier Type: -

Identifier Source: org_study_id