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Feasibility Study: Lifting and Tightening Neck Skin in Patients

NCT ID: NCT01708928

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

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Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.

Detailed Description

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This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Subjects who have previous history of submentoplasty and or rhytidectomy

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Group B

Subjects naïve to submentoplasty and or rhytidectomy

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, aged 30 to 65 years
* Subject in good health
* Body Mass index of less than 30
* Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
* Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
* Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
* 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 at Visit 1 and be willing able to use an acceptable method of birth control

Exclusion Criteria

* Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
* Has an active systemic or local skin disease that may alter wound healing
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
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 Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

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DeNova Research

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-107

Identifier Type: -

Identifier Source: org_study_id