Status:
COMPLETED
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
Lead Sponsor:
Solish, Nowell, M.D.
Conditions:
Aging
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patient...
Detailed Description
The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition...
Eligibility Criteria
Inclusion
- Male or Female \> 18 years of age
- Need for soft tissue augmentation as evidenced by any of the following:
- Bilateral-aging defects \> 1 on the Modified Fitzpatrick Wrinkle Scale
- Decrease in soft tissue volume in other areas of the face
Exclusion
- History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00911872
Start Date
January 1 2008
End Date
August 1 2008
Last Update
June 2 2009
Active Locations (1)
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1
Nowell Solish Private Practice
Toronto, Ontario, Canada