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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911872
• Other study ID #: E-ART
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: June 1, 2009
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: May 2009
• Source: Solish, Nowell, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• collagen (EVOLENCE)
injectable collagen

Locations

Country	Name	City	State
Canada	Nowell Solish Private Practice	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Solish, Nowell, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler		7 Days	No
Secondary	the immediate effects such as swelling, bleeding, bruising will be assessed		7 Days	Yes