Dermal Fillers Patient Satisfaction
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Purpose
The face is arguably the most critical aesthetic unit of the body. As humans begin to age, numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and changes in bony architecture. These changes are potentiated in our population secondary to sun exposure and smoking. To combat the effects of aging on the face, a multitude of products and procedures exist to attempt to reverse the effects of sun damage and aging to achieve a youthful and rejuvenated appearance. There has been a shift from invasive procedures such as a facelift to noninvasive means using filling agents to restore lost contour deformities.
The investigators hypothesis is that the use of dermal filling agents effectively delays the need for invasive procedures such as facelifts, and that patient satisfaction has increased with the evolution of recent dermal filling agents.
| Condition |
|---|
|
Loss of Facial Fat |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Dermal Filling Agents: Patient Satisfaction |
- Satisfaction with results of dermal filler [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Dermal Fillers
Facial Wasting
|
Detailed Description:
The first part of this study will involve a retrospective review of patients who have had a dermal filler injection between 01/01/1998 through 12/31/2008 and then following up with one (1) patient satisfaction survey. The first part of the study, which is retrospective, may involve approximately 500 subjects. The data collected from the retrospective review will be the subject's name, medical record number, and address for contact information. Any other data collected will come from the answers on the questionnaire.
The second part of this study will be a prospective study involving 100 subjects who are scheduled to have a dermal filler injection. These subjects will be asked to complete one (1) patient satisfaction survey two weeks after injection. Facial photos will be taken before the injection and then two weeks after injection at the follow up visit. This will complete the subject's participation in this study.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects who have an interest in combating the effects of facial aging with injectible dermal fillers.
Inclusion Criteria:
- Subjects from 21 - 80 years of age who are scheduled to have a dermal filler injection.
Exclusion Criteria:
- Subjects under 21 years of age or older than 80 years of age will be excluded from this study.
Contacts and Locations| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Lisa R David, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Lisa R. David, MD, Wake Forest University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01176812 History of Changes |
| Other Study ID Numbers: | 9251 |
| Study First Received: | August 5, 2010 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Facialwasting Juvederm Restylane |
ClinicalTrials.gov processed this record on May 16, 2013