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Clinical Trials/NCT00747422
NCT00747422
Completed
N/A

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

Ulthera, Inc4 sites in 1 country100 target enrollmentJuly 2008
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ConditionsPeriorbital Wrinkles

Overview

Phase
N/A
Intervention
Not specified
Conditions
Periorbital Wrinkles
Sponsor
Ulthera, Inc
Enrollment
100
Locations
4
Primary Endpoint
reduction of periorbital wrinkles
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
May 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

reduction of periorbital wrinkles

Time Frame: 3 and 6 months

Study Sites (4)

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