Skip to main content
OpenTrials
Completed

NCT Number: NCT00911872

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nowell Solish Private Practice

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collagen (EVOLENCE)

Device

injectable collagen

Other names: EVOLENCE and EVOLENCE BREEZE

Primary outcomes

  1. 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

  1. the immediate effects such as swelling, bleeding, bruising will be assessed

    Time frame: 7 Days

Sponsors and collaborators

Lead sponsor

Solish, Nowell, M.D.

Indiv

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 2, 2009
Registry last updated
Jun 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.