Dermal Fillers Patient Satisfaction
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2010 | ||||
| Last Updated Date | February 10, 2011 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Satisfaction with results of dermal filler [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01176812 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dermal Fillers Patient Satisfaction | ||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only | ||||
| 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. |
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| Condition ICMJE | Loss of Facial Fat | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Dermal Fillers
Facial Wasting |
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| Publications * | Not Provided | ||||
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* 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 ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | May 2015 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01176812 | ||||
| Other Study ID Numbers ICMJE | 9251 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lisa R. David, MD, Wake Forest University School of Medicine | ||||
| Study Sponsor ICMJE | Wake Forest School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest School of Medicine | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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