Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
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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 |
- Satisfaction with treatment with facial soft tissue fillers [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]
- 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:
|
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 |
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:
- Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.
Contacts and Locations| United States, New York | |
| The New York Eye & Ear Infirmary | |
| New York, New York, United States, 10003 | |
| 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 |
ClinicalTrials.gov processed this record on June 17, 2013