RhytidsNCT01034956
Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
An observational study of Rhytids and Wrinkles, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
Purpose of the study: The overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- hyaluronic acid or calcium hydroxylapatite filler
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years
Who may be able to join
- Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years willing to complete the research survey.
Who cannot join
- Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye & Ear Infirmary
New York, New York, 10003
About this study
Purpose of the study:
The overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Anthony P Sclafani, MD, FACS.
Participation:
Participants will be asked to complete a brief questionnaire regarding their most recent treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed anonymously.
Read the detailed description
Patients previously treated by the PI with dermal fillers will be mailed questionnaires about their experience with the treatment. These questionnaires will be deidentified prior to recording answers on a computer based spreadsheet.
- Being tested
- hyaluronic acid or calcium hydroxylapatite filler
- Keywords
- Soft tissue filler, Dermal filler, Complications, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid or calcium hydroxylapatite fillerDevice
Also called Restylane, Perlane, Juvederm, Radiesse
Intradermal and subdermal injection of facial soft tissue filler within the past 24 months; survey of patients to assess satisfaction and determine the presence of treatment related adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Facial Soft Tissue Filler Patients | Patients previously treated by Principal Investigator with facial soft tissue fillers within the past 2 years Receives: Device: hyaluronic acid or calcium hydroxylapatite filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with treatment with facial soft tissue fillers
Measured: 0-24 months
Secondary outcomes (1)
Social and behavioral effects of facial soft tissue filler treatment
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Anthony P. Sclafani, The New York Eye & Ear Infirmary
- Investigators
- Anthony P Sclafani, MD, Principal investigator, The New York Eye & Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034956
- Sponsor's protocol ID
- 09.27
- Status last verified
- Apr 2012
- First submitted
- 24 Nov 2009
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections
- ClinicalTrials.gov ID
- NCT01034956
- Acronym / sponsor ID
- 09.27
- Keywords
- Soft tissue filler, Dermal filler, Complications, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Dec 2009 (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.
Purpose of the study:
The overall goal of this study is to better understand patient experience with injectable facial fillers so that the investigators may provide the best results for their patients. To do this, the investigators are administering surveys to approximately 50 patients who have been treated by Dr. Anthony P Sclafani, MD, FACS.
Participation:
Participants will be asked to complete a brief questionnaire regarding their most recent treatment by Dr. Sclafani with a facial injectable filler. All responses will be analyzed anonymously.
Detailed description
Patients previously treated by the PI with dermal fillers will be mailed questionnaires about their experience with the treatment. These questionnaires will be deidentified prior to recording answers on a computer based spreadsheet.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Soft Tissue Filler Patients | – | Device: hyaluronic acid or calcium hydroxylapatite fillerPatients previously treated by Principal Investigator with facial soft tissue fillers within the past 2 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years
Key inclusion criteria (1 listed)
- Patients treated by Principal Investigator with facial soft tissue filler within the past 2 years willing to complete the research survey.
Key exclusion criteria (1 listed)
- Any patient not treated by Principal Investigator with facial soft tissue filler within the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid or calcium hydroxylapatite fillerAlso: Restylane, Perlane, Juvederm, RadiesseIntradermal and subdermal injection of facial soft tissue filler within the past 24 months; survey of patients to assess satisfaction and determine the presence of treatment related adverse events. | Device | Facial Soft Tissue Filler Patients |
Primary outcome
Satisfaction with treatment with facial soft tissue fillers
Time frame: 0-24 months
1 secondary outcome
Social and behavioral effects of facial soft tissue filler treatment
Time frame: 0-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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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.
Anthony P Sclafani, MD principal investigator
The New York Eye & Ear Infirmary
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 Rhytids and Wrinkles, run by The New York Eye & Ear Infirmary 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: finished, as of the sponsor's last update on 1 May 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 treatment with facial soft tissue fillers (time frame: 0-24 months). 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 1 May 2012.