NCT00911872

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
Last Updated

June 2, 2009

Status Verified

May 1, 2009

Enrollment Period

5 months

First QC Date

May 29, 2009

Last Update Submit

June 1, 2009

Conditions

Aging

Keywords

wrinklesdermal fillercollagensoft tissue augmentationaesthetic

Outcome Measures

Primary Outcomes (1)

  • Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler

    7 Days

Secondary Outcomes (1)

  • the immediate effects such as swelling, bleeding, bruising will be assessed

    7 Days

Study Arms (1)

aging

EXPERIMENTAL
Device: collagen (EVOLENCE)

Interventions

collagen (EVOLENCE)DEVICE

injectable collagen

Also known as: EVOLENCE and EVOLENCE BREEZE
aging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowell Solish Private Practice

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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. doi: 10.1016/j.jaad.2009.08.016.

    PMID: 20398812DERIVED

Study Officials

  • Nowell Solish, MD

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

June 2, 2009

Record last verified: 2009-05

Locations

CA(1)