EVOLENCE® Assessment of Recovery Time and Impact of Derma... | NCT00911872

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

NCT00911872

Sponsor

Solish, Nowell, M.D.

Status

Completed

Last Update Posted

Jun 2, 2009Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Aging

Interventions

collagen (EVOLENCE)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

May 29, 2009

First Submission Date that Met QC Criteria

Jun 1, 2009

First Posted Date

Jun 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2009

Last Update Posted Date

Jun 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aging	Experimental		Device: collagen (EVOLENCE)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
collagen (EVOLENCE)	Device	injectable collagen	aging	EVOLENCE and EVOLENCE BREEZE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler		7 Days

Secondary Outcomes

Measure	Description	Time Frame
the immediate effects such as swelling, bleeding, bruising will be assessed		7 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nowell Solish, MD	Private Practice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nowell Solish Private Practice		Toronto	Ontario		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20398812	Derived	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.