MedDataX Logo

Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

NCT ID: NCT01368835

Last Updated: 2017-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.

The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild to Moderate Skin Laxity on Cheek Mild to Moderate Skin Laxity on Upper Neck Mild to Moderate Subcutaneous Fat on Cheek Mild to Moderate Subcutaneous Fat on Upper Neck

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ulthera treatment

Group Type EXPERIMENTAL

Ulthera treatment

Intervention Type DEVICE

treatment of cheeks and upper neck area of face

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ulthera treatment

treatment of cheeks and upper neck area of face

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, aged 35 to 60 years
* Subject in good health
* Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

Exclusion Criteria

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Has significant scarring in areas to be treated
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey M. Kenkel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ULT-106

Identifier Type: -

Identifier Source: org_study_id