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Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

NCT ID: NCT01708252

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

Detailed Description

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This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ulthera treatment group

All subjects will receive an Ulthera System Treatment

Group Type EXPERIMENTAL

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.
* BMI \< 30.
* Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
* Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
* Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.

Exclusion Criteria

* Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat on the cheeks.
* Excessive skin laxity on the lower face and 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 Dayan, MD, FACS

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-127

Identifier Type: -

Identifier Source: org_study_id