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Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

NCT ID: NCT01368874

Last Updated: 2017-12-13

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

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This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

Detailed Description

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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Conditions

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Facial and Neck Skin Laxity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.

Group Type ACTIVE_COMPARATOR

Ulthera® System treatment

Intervention Type DEVICE

Single treatment of focused ultrasound energy delivered below the surface of the skin.

Group B

Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.

Group Type ACTIVE_COMPARATOR

Ulthera® System treatment

Intervention Type DEVICE

Single treatment of focused ultrasound energy delivered below the surface of the skin.

Group C

Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.

Group Type ACTIVE_COMPARATOR

Ulthera® System treatment

Intervention Type DEVICE

Single treatment of focused ultrasound energy delivered below the surface of the skin.

Interventions

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Ulthera® System treatment

Single treatment of 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, aged 30 to 65 years.
* Subject in good health.
* Skin laxity in the lower face and neck.
* Willingness and ability to comply with protocol requirements and return for follow-up visits.
* Provides written informed consent and HIPAA authorization.

Exclusion Criteria

* Pregnant or lactating.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and lower neck.
* Excessive skin laxity on the face and neck.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne on the face.
* Presence of a metal stent or implant in the facial 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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Leslie Baumann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baumann Cosmetic and Research Institute

Brian Zelickson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zel Skin and Laser Specialist

Locations

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Baumann Cosmetic and Research Institute

Miami Beach, Florida, United States

Site Status

Zel Skin and Laser Specialists

Edina, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-110

Identifier Type: -

Identifier Source: org_study_id