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

Not Applicable

Completed

• Conditions: Periorbital Wrinkles
• Interventions: Device: Ulthera™ System

• Registration Number: NCT00747422
• Lead Sponsor: Ulthera, Inc

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2008-12
• Study Completion: 2009-05
• Status Verified: 2012-10
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Ulthera™ System	-

Primary Outcome Measures

Name	Time	Method
reduction of periorbital wrinkles	3 and 6 months

Trial Locations

Locations (4)

Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology; 🇺🇸 San Diego, California, United States

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States

SkinCare Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States

Zel Skin and Laser Specialists; 🇺🇸 Edina, Minnesota, United States