Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

This study has been completed.
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Anthony P. Sclafani, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01034956
First received: November 24, 2009
Last updated: April 29, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Rhytids
Wrinkles
Device: hyaluronic acid or calcium hydroxylapatite filler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

Resource links provided by NLM:


Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Satisfaction with treatment with facial soft tissue fillers [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social and behavioral effects of facial soft tissue filler treatment [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Other Names:
  • Restylane
  • Perlane
  • Juvederm
  • Radiesse

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.

  Eligibility

Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034956

Locations
United States, New York
The New York Eye & Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Thomas Jefferson University
Investigators
Principal Investigator: Anthony P Sclafani, MD The New York Eye & Ear Infirmary
  More Information

No publications provided

Responsible Party: Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT01034956     History of Changes
Other Study ID Numbers: 09.27
Study First Received: November 24, 2009
Last Updated: April 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
Soft tissue filler
Dermal filler
Complications
Patient satisfaction

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014