Dermal Fillers Patient Satisfaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176812
Recruitment Status : Withdrawn (Difficult to recruit subjects in the area.)
First Posted : August 6, 2010
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease
Loss of Facial Fat

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
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Dermal Filling Agents: Patient Satisfaction
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Dermal Fillers
Facial Wasting

Primary Outcome Measures :
  1. Satisfaction with results of dermal filler [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176812

United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Lisa R David, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Identifier: NCT01176812     History of Changes
Other Study ID Numbers: 9251
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: February 2011

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):