Aging
Conditions
Keywords
wrinkles, dermal filler, collagen, soft tissue augmentation, aesthetic
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.
Interventions
DEVICEcollagen (EVOLENCE)
injectable collagen
Sponsors
Solish, Nowell, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler | 7 Days |
Secondary
| Measure | Time frame |
|---|---|
| the immediate effects such as swelling, bleeding, bruising will be assessed | 7 Days |
Countries
Canada
Outcome results
None listed