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A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

NCT ID: NCT01519934

Last Updated: 2017-12-18

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

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

Brief Summary

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Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Detailed Description

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This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Conditions

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Skin Laxity Wrinkles

Keywords

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Ulthera® System Ultherapy™ Treatment Ulthera, Inc. Ultrasound treatment for skin tightening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ulthera-treated subjects

All enrolled subjects will have received an Ulthera treatment prior to enrollment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 25-85 years.
* Subject in good health.
* Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
* Absence of physical or psychological conditions unacceptable to the investigator.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Significant scarring in areas treated.
* Open wounds or lesions in the areas treated.
* Severe or cystic acne on the areas treated.
* Inability to understand the protocol or to give informed consent.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 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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Mitchel Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Cosmetic Laser Associates

Locations

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Dermatology Cosmetic Laser Associates

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-120

Identifier Type: -

Identifier Source: org_study_id