Status:
COMPLETED
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Lead Sponsor:
Ulthera, Inc
Conditions:
Skin Laxity
Wrinkles
Eligibility:
All Genders
25-85 years
Brief Summary
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur a...
Detailed Description
This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic ...
Eligibility Criteria
Inclusion
- Male or female, age 25-85 years.
- Subject in good health.
- Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
- Absence of physical or psychological conditions unacceptable to the investigator.
Exclusion
- Presence of an active systemic or local skin disease that may affect wound healing.
- Significant scarring in areas treated.
- Open wounds or lesions in the areas treated.
- Severe or cystic acne on the areas treated.
- Inability to understand the protocol or to give informed consent.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01519934
Start Date
October 1 2011
End Date
August 1 2012
Last Update
December 18 2017
Active Locations (1)
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1
Dermatology Cosmetic Laser Associates
San Diego, California, United States, 92121