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Lifting and Tightening of the Face in Subjects With Skin of Darker Color

NCT ID: NCT01368965

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Conditions

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Facial Skin Laxity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ulthera® System treatment

Group Type EXPERIMENTAL

Ulthera® System treatment

Intervention Type DEVICE

Ulthera® System treatment delivering focused ultrasound energy

Interventions

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Ulthera® System treatment

Ulthera® System treatment delivering focused ultrasound energy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
* Fitzpatrick skin phototypes of 3 through 6.
* Provide 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 on the cheek.
* Excessive skin laxity on the lower 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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Hema Sundaram, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Cosmetic & Laser Surgery

Monte O Harris, M.D.

Role: PRINCIPAL_INVESTIGATOR

Harris Aesthetics, LLC

Locations

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Harris Aesthetics, LLC

Chevy Chase, Maryland, United States

Site Status

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, United States

Site Status

Countries

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United States

References

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Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.

Reference Type DERIVED
PMID: 26313402 (View on PubMed)

Other Identifiers

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ULT-112

Identifier Type: -

Identifier Source: org_study_id