Dermal Fillers Patient Satisfaction
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ClinicalTrials.gov Identifier: NCT01176812 |
Recruitment Status
:
Withdrawn
(Difficult to recruit subjects in the area.)
First Posted
: August 6, 2010
Last Update Posted
: November 7, 2017
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Tracking Information | ||||
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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 |
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. |
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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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Other |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Withdrawn | |||
Actual Enrollment |
0 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Wake Forest University Health Sciences | |||
Verification Date | February 2011 |