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Evaluation of the Ulthera® System for Treatment of the Face and Neck

NCT ID: NCT01713907

Last Updated: 2017-11-24

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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 is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Conditions

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Wrinkles Rhytids Skin Laxity

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ulthera® treatment

All enrolled subjects will receive one full face and neck Ulthera® treatment.

Group Type EXPERIMENTAL

Ulthera® Treatment

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™ System Ulthera, Inc.

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
* Mild to moderate rhytids in the periorbital or perioral region.
* Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
* Mild to moderate vertical perioral lines
* Mild to moderate marionette lines.
* Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* 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.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat on the cheek.
* Excessive skin laxity on the lower face and neck.
* Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
* Excessive hooding with or without redundant skin in the areas 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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Hema Sundaram, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Cosmetic & Laser Surgery

Locations

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Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-109

Identifier Type: -

Identifier Source: org_study_id