NCT00911872CompletedNot Applicable
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
Solish, Nowell, M.D.1 site in 1 country30 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
Study Overview
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 patients to feel comfortable with the results, and return to their normal daily routine is also of important interest
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, the immediate effects such as swelling, bleeding, bruising will be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
Time Frame: 7 Days
Secondary Outcomes
- the immediate effects such as swelling, bleeding, bruising will be assessed(7 Days)
Investigators
Study Sites (1)
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