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

Sponsor
Solish, Nowell, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT00911872
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
7
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: collagen (EVOLENCE)
 N/A

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

Study Type:
Interventional
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 :
Jan 1, 2008
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: aging

Device: collagen (EVOLENCE)
injectable collagen
Other Names:
  • EVOLENCE and EVOLENCE BREEZE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler [7 Days]

    Secondary Outcome Measures

    1. the immediate effects such as swelling, bleeding, bruising will be assessed [7 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Nowell Solish Private Practice Toronto Ontario Canada

    Sponsors and Collaborators

    • Solish, Nowell, M.D.

    Investigators

    • Principal Investigator: Nowell Solish, MD, Private Practice

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00911872
    Other Study ID Numbers:
    • E-ART
    First Posted:
    Jun 2, 2009
    Last Update Posted:
    Jun 2, 2009
    Last Verified:
    May 1, 2009
    Keywords provided by , ,
    wrinkles
    dermal filler
    collagen
    soft tissue augmentation
    aesthetic

    Study Results

    No Results Posted as of Jun 2, 2009