Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

Ulthera, Inc2 sites in 1 country68 target enrollmentMarch 2011

ConditionsPeriorbital Wrinkles

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Periorbital Wrinkles
Sponsor: Ulthera, Inc
Enrollment: 68
Locations: 2
Primary Endpoint: Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Detailed Description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

January 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ulthera, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, aged 30 to 65 years.
•Subject in good health.
•Mild to moderate rhytids in the periorbital region.
•Willingness and ability to comply with protocol requirements and return for follow-up visits.
•Not pregnant.
•Provide written informed consent and HIPAA authorization.

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.
•Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
•Excessive hooding, with or without redundant skin, in the areas to be treated.
•Significant scarring in areas to be treated.
•Significant open facial wounds or lesions.
•Severe or cystic acne on the face.
•Presence of a metal stent or implant in the facial area to be treated.

Outcomes

Primary Outcomes

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes

Time Frame: 90 days post-treatment

Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.

Secondary Outcomes

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment(90 days post-treatment)
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment(60 days post-treatment)
Patient Satisfaction Questionnaire at 180 Days Post-treatment(180 days post-treatment)
Patient Satisfaction Questionnaire 90 Days Post-treatment(90 days post-treatment)
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment(180 days post-treatment)