Evaluation of the Effectiveness and Safety of the Ulthera... | NCT00747422

Studies
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

NCT00747422

Sponsor

Ulthera, Inc

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Periorbital Wrinkles

Interventions

Ulthera™ System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2008Actual

Completion Date

May 2009Actual

First Submitted Date

Sep 3, 2008

First Submission Date that Met QC Criteria

Sep 4, 2008

First Posted Date

Sep 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2017

Last Update Posted Date

Nov 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

Detailed Description

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental		Device: Ulthera™ System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ulthera™ System	Device	ultrasound treatment	I

Measure	Description	Time Frame
reduction of periorbital wrinkles		3 and 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged 40 to 70 years
Subject in good health
Desire improvement in periorbital wrinkles
Subject provides informed consent and agrees to attend follow-up visits
Subject signs a HIPPA authorization

Exclusion Criteria:

Pregnant or lactating
Has an active systemic or local skin disease that may alter wound healing
Has significant scarring in test areas
Has significant open facial wounds or lesions
Has severe or cystic acne on the face
Has a metal stent or implant in the face area
Is a current smoker or has a history of smoking in last 10 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology		San Diego	California	92130	United States