Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

NCT01034956 | Completed

• 1 other identifier: 09.27
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhytids; Wrinkles

Keywords

Soft tissue filler; Dermal filler; Complications; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Satisfaction with treatment with facial soft tissue fillers

  0-24 months

Secondary Outcomes (1)

• Social and behavioral effects of facial soft tissue filler treatment

  0-24 months

Study Arms (1)

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

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.

Also known as: Restylane, Perlane, Juvederm, Radiesse

Facial Soft Tissue Filler Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

The New York Eye & Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anthony P Sclafani, MD

  The New York Eye & Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Facial Plastic Surgery

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: December 18, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

US (1)