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

Not Applicable

Completed

• Conditions: Aging
• Interventions: Device: collagen (EVOLENCE)

• Registration Number: NCT00911872
• Lead Sponsor: Solish, Nowell, M.D.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2009-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Last Update Submitted: 2009-06-01
• Study First Posted: 2009-06-02
• Last Update Posted: 2009-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aging	collagen (EVOLENCE)	-

Primary Outcome Measures

Name	Time	Method
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler	7 Days

Secondary Outcome Measures

Name	Time	Method
the immediate effects such as swelling, bleeding, bruising will be assessed	7 Days

Trial Locations

Locations (1)

Nowell Solish Private Practice; 🇨🇦 Toronto, Ontario, Canada