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Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

NCT ID: NCT01713985

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

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This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also 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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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Ulthera System Treatment Right, Thermage Left

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Thermage

Intervention Type DEVICE

Radiofrequency treatment focusing radiofrequency energy

Group B

Ulthera System Treatment Left, Thermage Right

Group Type ACTIVE_COMPARATOR

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Thermage

Intervention Type DEVICE

Radiofrequency treatment focusing radiofrequency energy

Interventions

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Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Thermage

Radiofrequency treatment focusing radiofrequency energy

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.
* Skin laxity on the area(s) to be treated.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* 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.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the area(s) to be treated.
* Excessive skin laxity on the area(s) to be treated.
* Significant scarring in the area(s) to be treated.
* Open wounds or lesions in the area(s) to be treated.
* Severe or cystic acne on the area(s) to be treated.
* Presence of a metal stent or implant in the area(s) to be treated.
* Inability to understand the protocol or to give informed consent.
* Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
* Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
* BMI equal to or greater than 25.
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 Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Faces+

Locations

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FACES+

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-135

Identifier Type: -

Identifier Source: org_study_id