Outcomes and Patient Experience After Soft Tissue Dermal... | NCT01034956

Studies
Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

NCT01034956

Sponsor

The New York Eye & Ear Infirmary

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Rhytids
Wrinkles

Interventions

hyaluronic acid or calcium hydroxylapatite filler

Countries

United States

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

Apr 2012

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

Nov 2009

Primary Completion Date

Mar 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 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

Apr 29, 2012

Last Update Posted Date

May 1, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear InfirmaryPrincipal Investigator

Lead Sponsor

The New York Eye & Ear InfirmaryOTHER

Collaborators

Name	Class
Thomas Jefferson University	OTHER

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

Purpose of the study:

The overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Anthony P Sclafani, MD, FACS.

Participation:

Participants will be asked to complete a brief questionnaire regarding their most recent treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed anonymously.

Detailed Description

Patients previously treated by the PI with dermal fillers will be mailed questionnaires about their experience with the treatment. These questionnaires will be deidentified prior to recording answers on a computer based spreadsheet.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Facial Soft Tissue Filler Patients		Patients previously treated by Principal Investigator with facial soft tissue fillers within the past 2 years	Device: hyaluronic acid or calcium hydroxylapatite filler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyaluronic acid or calcium hydroxylapatite filler	Device	Intradermal and subdermal injection of facial soft tissue filler within the past 24 months; survey of patients to assess satisfaction and determine the presence of treatment related adverse events.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction with treatment with facial soft tissue fillers		0-24 months

Secondary Outcomes

Measure	Description	Time Frame
Social and behavioral effects of facial soft tissue filler treatment		0-24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years willing to complete the research survey.

Exclusion Criteria:

Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony P Sclafani, MD	The New York Eye & Ear Infirmary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The New York Eye & Ear Infirmary		New York	New York	10003	United States

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided