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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:
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
History of Changes

May 29, 2009
June 1, 2009
January 2008
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00911872 on ClinicalTrials.gov Archive Site
the immediate effects such as swelling, bleeding, bruising will be assessed [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

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

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aging
Device: collagen (EVOLENCE)
injectable collagen
Other Name: EVOLENCE and EVOLENCE BREEZE
Experimental: aging
Intervention: Device: collagen (EVOLENCE)
Solish NJ. Assessment of recovery time for the collagen products Dermicol-P35 27G and 30G. J Am Acad Dermatol. 2010 May;62(5):824-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00911872
E-ART
No
Dr. Nowell Solish, Private Practice
Solish, Nowell, M.D.
Not Provided
Principal Investigator: Nowell Solish, MD Private Practice
Solish, Nowell, M.D.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP