Status:
COMPLETED
Ultherapy™ Treatment Following Sculptra® Treatment
Lead Sponsor:
Ulthera, Inc
Conditions:
Skin Laxity
Eligibility:
All Genders
35-60 years
Phase:
NA
Brief Summary
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Detailed Description
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per g...
Eligibility Criteria
Inclusion
- Male or female, aged 35 to 60 years.
- Subject in good health.
- Skin laxity in the lower face and neck.
- Grade 1 and 2 on the Knize Scale
Exclusion
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face and neck.
- Excessive skin laxity on the face and neck.
- No scarring in areas to be treated.
- Any open facial wounds or lesions.
- Acne on the face.
- Patients who have a history with keloid formation or hypertropic scarring
- Patients who have a hypersensitivity to injectable poly-L-lactic acid
- Presence of a metal stent or implant in the facial area to be treated.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01422538
Start Date
May 1 2011
End Date
September 1 2012
Last Update
December 13 2017
Active Locations (1)
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1
EpiCentre Park Lane
Dallas, Texas, United States, 75231