Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00911872
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : June 2, 2009
Sponsor:
Information provided by:
Solish, Nowell, M.D.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Aging Device: collagen (EVOLENCE) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: aging Device: collagen (EVOLENCE)
injectable collagen
Other Name: EVOLENCE and EVOLENCE BREEZE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Canada, Ontario
Nowell Solish Private Practice
Toronto, Ontario, Canada
Sponsors and Collaborators
Solish, Nowell, M.D.
Investigators
Layout table for investigator information
Principal Investigator: Nowell Solish, MD Private Practice
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Dr. Nowell Solish, Private Practice
ClinicalTrials.gov Identifier: NCT00911872    
Other Study ID Numbers: E-ART
First Posted: June 2, 2009    Key Record Dates
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