EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

Solish, Nowell, M.D.30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aging

Interventions

collagen (EVOLENCE)DEVICE

injectable collagen

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nowell Solish Private Practice

Toronto, Ontario, Canada

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

Time frame: 7 Days

Data from ClinicalTrials.gov

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