Loss of Facial FatNCT01176812
Dermal Fillers Patient Satisfaction
An observational study of Loss of Facial Fat, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Loss of Facial Fat
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have an interest in combating the effects of facial aging with injectible dermal fillers.
Who may be able to join
- Subjects from 21 - 80 years of age who are scheduled to have a dermal filler injection.
Who cannot join
- Subjects under 21 years of age or older than 80 years of age will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Loss of Facial Fat
- Keywords
- Facialwasting, Juvederm, Restylane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dermal Fillers | Facial Wasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with results of dermal filler
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Difficult to recruit subjects in the area.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Facial FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa R David, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176812
- Sponsor's protocol ID
- 9251
- Status last verified
- Feb 2011
- First submitted
- 5 Aug 2010
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Filling Agents: Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01176812
- Acronym / sponsor ID
- 9251
- Conditions
- Loss of Facial Fat
- Keywords
- Facialwasting, Juvederm, Restylane
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit subjects in the area.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermal Fillers | – | –Facial Wasting |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have an interest in combating the effects of facial aging with injectible dermal fillers.
Key inclusion criteria (1 listed)
- Subjects from 21 - 80 years of age who are scheduled to have a dermal filler injection.
Key exclusion criteria (1 listed)
- Subjects under 21 years of age or older than 80 years of age will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction with results of dermal filler
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Related trials for Loss of Facial Fat
Not yet recruiting
Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
Facial Atrophy and Loss of Contour
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R David, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loss of Facial Fat, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with results of dermal filler (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.