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

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.

Completed

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Key information

Conditions

Periorbital Wrinkles

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulthera™ System

Device

ultrasound treatment

Primary outcomes

reduction of periorbital wrinkles

Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Sep 5, 2008
Registry last updated: Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed