Dermal Fillers Patient Satisfaction

This study has been terminated.
(Difficult to recruit subjects in the area.)
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01176812
First received: August 5, 2010
Last updated: February 10, 2011
Last verified: February 2011

August 5, 2010
February 10, 2011
May 2009
May 2014   (final data collection date for primary outcome measure)
Satisfaction with results of dermal filler [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01176812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermal Fillers Patient Satisfaction
Dermal Filling Agents: Patient Satisfaction

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.

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.

Observational
Observational Model: Case-Only
Not Provided
Not Provided
Non-Probability Sample

Subjects who have an interest in combating the effects of facial aging with injectible dermal fillers.

Loss of Facial Fat
Not Provided
Dermal Fillers
Facial Wasting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
May 2015
May 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01176812
9251
No
Lisa R. David, MD, Wake Forest University School of Medicine
Wake Forest School of Medicine
Not Provided
Principal Investigator: Lisa R David, MD Wake Forest School of Medicine
Wake Forest School of Medicine
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP