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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911872
First Posted: June 2, 2009
Last Update Posted: June 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solish, Nowell, M.D.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 29, 2009
First Posted: June 2, 2009
Last Update Posted: June 2, 2009
Last Verified: May 2009

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