Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

Wrinkles Clinical Trial

Official title:

Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034956
• Other study ID #: 09.27
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: April 29, 2012
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2012
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Rhytids
• Wrinkles

Intervention

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.

Locations

Country	Name	City	State
United States	The New York Eye & Ear Infirmary	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with treatment with facial soft tissue fillers		0-24 months	No
Secondary	Social and behavioral effects of facial soft tissue filler treatment		0-24 months	No