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
  Purpose

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
Loss of Facial Fat

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Dermal Filling Agents: Patient Satisfaction

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Satisfaction with results of dermal filler [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dermal Fillers
Facial Wasting

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176812

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

No publications provided

Responsible Party: Lisa R. David, MD, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT01176812     History of Changes
Other Study ID Numbers: 9251
Study First Received: August 5, 2010
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Facialwasting
Juvederm
Restylane

ClinicalTrials.gov processed this record on September 22, 2014