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Ultherapy™ Treatment Following Sculptra® Treatment

NCT ID: NCT01422538

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-09-30

Brief Summary

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This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Detailed Description

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This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Conditions

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Skin Laxity

Keywords

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Ulthera® System Ultherapy™ treatment Ulthera, Inc. Ultrasound treatment for skin tightening Skin laxity on the face and neck.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Subjects will receive Ulthera® System alone.

Group Type ACTIVE_COMPARATOR

Ulthera® System

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin on the lower face.

Group B

Sculptra® only

Group Type ACTIVE_COMPARATOR

Sculptra®

Intervention Type DRUG

Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.

Group C

Sculptra® treatment followed by Ultherapy™ treatment

Group Type ACTIVE_COMPARATOR

Sculptra® treatment followed by Ultherapy™ treatment

Intervention Type OTHER

Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Interventions

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Ulthera® System

Focused ultrasound energy delivered below the surface of the skin on the lower face.

Intervention Type DEVICE

Sculptra®

Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.

Intervention Type DRUG

Sculptra® treatment followed by Ultherapy™ treatment

Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Intervention Type OTHER

Other Intervention Names

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Ultherapy™ Poly-L-Lactic acid fillers

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 35 to 60 years.
* Subject in good health.
* Skin laxity in the lower face and neck.
* Grade 1 and 2 on the Knize Scale

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and neck.
* Excessive skin laxity on the face and neck.
* No scarring in areas to be treated.
* Any open facial wounds or lesions.
* Acne on the face.
* Patients who have a history with keloid formation or hypertropic scarring
* Patients who have a hypersensitivity to injectable poly-L-lactic acid
* Presence of a metal stent or implant in the facial area to be treated.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 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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Jay Burns, MD

Role: PRINCIPAL_INVESTIGATOR

EpiCentre Park Lane

Locations

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EpiCentre Park Lane

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-113

Identifier Type: -

Identifier Source: org_study_id