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CompletedNCT01034956Updated May 1, 2012

Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

An observational study in Rhytids and Wrinkles, sponsored by The New York Eye & Ear Infirmary. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-05-01.

Sponsored by The New York Eye & Ear Infirmary · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rhytids
  • Wrinkles

Keywords

  • Soft tissue filler
  • Dermal filler
  • Complications
  • Patient satisfaction
03

In context

Lead sponsor

The New York Eye & Ear Infirmary is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (actual)

Groups and cohorts

  • 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

  • Devicehyaluronic acid or calcium hydroxylapatite filler

    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.

    Also known as: Restylane, Perlane, Juvederm, Radiesse

06

What researchers measure

Primary outcomes

  1. Satisfaction with treatment with facial soft tissue fillers

    Time frame: 0-24 months

Secondary outcomes

  1. Social and behavioral effects of facial soft tissue filler treatment

    Time frame: 0-24 months

07

Study locations

1 site
  • The New York Eye & Ear Infirmary
    New York, New York 10003, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01034956
Lead sponsor
The New York Eye & Ear Infirmary
Collaborators
Thomas Jefferson University
Responsible party
Anthony P. Sclafani (Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary) — Principal investigator
First posted
Dec 18, 2009
Start date
Nov 2009
Primary completion
Mar 2010
Completion
May 2010
Last update
May 1, 2012

Study contacts

Anthony P Sclafani, MD
principal investigator · The New York Eye & Ear Infirmary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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