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

This study has been completed.
Sponsor:
Information provided by:
Solish, Nowell, M.D.
ClinicalTrials.gov Identifier:
NCT00911872
First received: May 29, 2009
Last updated: June 1, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention
Aging
Device: collagen (EVOLENCE)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

Further study details as provided by Solish, Nowell, M.D.:

Primary Outcome Measures:
  • Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the immediate effects such as swelling, bleeding, bruising will be assessed [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aging Device: collagen (EVOLENCE)
injectable collagen
Other Name: EVOLENCE and EVOLENCE BREEZE

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911872

Locations
Canada, Ontario
Nowell Solish Private Practice
Toronto, Ontario, Canada
Sponsors and Collaborators
Solish, Nowell, M.D.
Investigators
Principal Investigator: Nowell Solish, MD Private Practice
  More Information

No publications provided by Solish, Nowell, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Nowell Solish, Private Practice
ClinicalTrials.gov Identifier: NCT00911872     History of Changes
Other Study ID Numbers: E-ART
Study First Received: May 29, 2009
Last Updated: June 1, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Solish, Nowell, M.D.:
wrinkles
dermal filler
collagen
soft tissue augmentation
aesthetic

ClinicalTrials.gov processed this record on August 26, 2014