Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
1 other identifier
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2008
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 24, 2017
October 1, 2012
5 months
September 3, 2008
November 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
reduction of periorbital wrinkles
3 and 6 months
Study Arms (1)
I
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulthera, Inclead
Study Sites (4)
Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology
San Diego, California, 92130, United States
Northwestern University Department of Dermatology
Chicago, Illinois, 60611, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467, United States
Zel Skin and Laser Specialists
Edina, Minnesota, 55424, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 5, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2008
Study Completion
May 1, 2009
Last Updated
November 24, 2017
Record last verified: 2012-10