Dermal Fillers Patient Satisfaction

Tracking Information
First Submitted Date	August 5, 2010
First Posted Date	August 6, 2010
Last Update Posted Date	November 7, 2017
Study Start Date	May 2009
Actual Primary Completion Date	May 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 5, 2010)	Satisfaction with results of dermal filler [ Time Frame: 1 year ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01176812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Dermal Fillers Patient Satisfaction
Official Title	Dermal Filling Agents: Patient Satisfaction
Brief Summary	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.
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.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Other
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subjects who have an interest in combating the effects of facial aging with injectible dermal fillers.
Condition	Loss of Facial Fat
Intervention	Not Provided
Study Groups/Cohorts	Dermal Fillers; Facial Wasting
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Withdrawn
Actual Enrollment; (submitted: September 17, 2015)	0
Original Estimated Enrollment; (submitted: August 5, 2010)	600
Actual Study Completion Date	May 2010
Actual Primary Completion Date	May 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01176812
Other Study ID Numbers	9251
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor	Wake Forest University
Collaborators	Not Provided
Investigators	Principal Investigator: Lisa R David, MD Wake Forest University Health Sciences
PRS Account	Wake Forest University Health Sciences
Verification Date	February 2011