Skin AgingCOAL2NCT05419609
Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift
A study testing Limited facelift, Full facelift and FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline in people with Skin Aging and Facial Asymmetry, run by Dufresne, Craig, MD, PC at 1 site in United States.
Trial summary
To compare safety, patient satisfaction, and technical correction between a limited and full facelift, patients meeting strict clinical and safety criteria for both types of facelift will be randomly assigned to have one of these procedures. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Facial Asymmetry, Aging Problems
- What is being tested?
- Limited facelift, Full facelift and FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to Jul 2023
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient willing to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital
- Patient willing and able to accept financial responsibilities of undergoing either type of facelift.
- Patient able to provide informed consent
- Between age 40-years-old and 85-years-old
- No history of bleeding disorder
- BMI <25
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- Stable weight
- Does not have implanted cardiac device
- Minimal anxiety
- No history of smoking
- Stable, good health
- Normal blood pressure or well-controlled hypertension
- Surgeon believes patient could tolerate and safely undergo either a limited facelift done in the office or a full facelift done in the hospital
Who cannot join
- Patient refusal to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital
- Patient not willing or not able to accept financial responsibilities of undergoing either type of facelift.
- Patient unable to provide informed consent
- Under age 40-years-old or over 85-years-old
- History of bleeding disorder
- BMI >25
Show all 13Show fewer
- Unstable weight
- Has implanted cardiac device
- Significant anxiety
- History of smoking
- Significant active disease (e.g., dementia, cancer, chronic respiratory illness, heart disease, etc.)
- Uncontrolled hypertension
- Surgeon believes patient could not tolerate or safely undergo either a limited facelift done in the office or a full facelift done in the hospital
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Office of Craig R Dufresne, MD, PC
Fairfax, Virginia, 22031
Craig R Dufresne, MD, 703-207-3065, info@duplastics.com
Mikaela I Poling, BA, 703-207-3065, research@duplastics.com
About this study
Official title: Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study
To compare safety, patient satisfaction, and technical correction between a limited and full facelift, patients meeting strict clinical and safety criteria for both types of facelift will be randomly assigned to have one of these procedures. In the context of this study, a limited facelift is done in the office under local anesthesia, and a full facelift is done in the hospital or ambulatory surgical center with either general anesthesia or intravenous sedation.
Read the detailed description
While there are previous reports of facelift in an office-based setting without general anesthesia or intravenous sedation, these reports included patient demographic information, medical history, and complication rates only and did not compare their office-based facelift with a full facelift done in the hospital or ambulatory surgical center. Previous reports also included oral sedation for all patients.
The current study will address these gaps in what is known about office-based limited facelifts done with local anesthesia. Finally, the study will also ascertain patient satisfaction at 3 points-at the pre-operative visit, early post-operative visit, and final visit-using selected modules from the validated FACE-Q | Aesthetics survey.
- Conditions
- Skin Aging, Facial Asymmetry, Aging Problems
- Being tested
- Limited facelift, Full facelift, FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline, FACE-Q | Aesthetics - Recovery Early Symptoms, FACE-Q | Aesthetics - Satisfaction with Outcome
- Keywords
- Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System
- Medical subject headings
- Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited faceliftProcedure or surgery
Also called Limited dissection SMAS manipulation
A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
Full faceliftProcedure or surgery
Also called SMAS manipulation
A full face and neck lift that addresses signs of aging in the face and neck
FACE-Q | Aesthetics - Satisfaction With Lower Face and JawlineOther
Completed by patients. The FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline is a 5-item questionnaire. Each item is rated 1-4, with 1 being "Very Dissatisfied" and 4 being "Very Satisfied". Lower scores suggest the person may be less pleased with the appearance of their lower face and jawline.
FACE-Q | Aesthetics - Recovery Early SymptomsOther
Completed by patients. The FACE-Q | Aesthetics - Recovery Early Symptoms is a 17-item questionnaire. Each item is rated 1-4, with 1 being "Not at all" and 4 being "Extremely". Lower scores suggest the person may be experiencing fewer symptoms early in their recovery following an aesthetic facial procedure.
FACE-Q | Aesthetics - Satisfaction with OutcomeOther
Completed by patients. The FACE-Q | Aesthetics - Satisfaction with Outcome is a 6-item questionnaire. Each item is rated 1-4, with 1 being "Definitely disagree" and 4 being "Definitely agree". Lower scores suggest the person may be less pleased with their final appearance following surgery and the decision to have an aesthetic facial procedure.
FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, NeckOther
Completed by patients. The FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck is a 15-item questionnaire. Each item is rated 1-3, with 1 being "Not at all" and 3 being "A lot". Lower scores suggest the person may be experiencing fewer chronic symptoms following an aesthetic facial procedure.
| Study group | Role | What they receive |
|---|---|---|
| Office-based limited facelift | Experimental | Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication. Receives: Procedure: Limited facelift; Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline; Other: FACE-Q | Aesthetics - Recovery Early Symptoms; Other: FACE-Q | Aesthetics - Satisfaction with Outcome; Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck |
| Hospital-based full facelift | Active comparator | Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation. Receives: Procedure: Full facelift; Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline; Other: FACE-Q | Aesthetics - Recovery Early Symptoms; Other: FACE-Q | Aesthetics - Satisfaction with Outcome; Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
Post-operative adverse effects may be acute, such as hematoma or infection, or they may become apparent later, such as nerve injury. Not all post-operative adverse effects will require treatment, such as mild pain, swelling, or bruising.
Measured: 1 hour following surgery and 2 weeks following surgery
Difference in post-operative aesthetic correction rating between groups
Post-operative aesthetic correction rating is completed based on comparison with pre-operative photographs. Ratings possible are 1 (no improvement) to 5 (excellent).
Measured: an average of 1 year following surgery
Secondary outcomes (1)
Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit
The "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" is a validated patient satisfaction survey for the lower face and jawline.
Measured: an average of 30 days before surgery and again an average of 1 year following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start30 Jun 2022
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dufresne, Craig, MD, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig R Dufresne, MD, Principal investigator, Office of Dr Craig R Dufresne, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419609
- Sponsor's protocol ID
- U1111-1278-8245
- Acronym
- COAL2
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05419609
- Acronym / sponsor ID
- COAL2 / U1111-1278-8245
- Conditions
- Skin Aging, Facial Asymmetry, Aging Problems
- Keywords
- Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dufresne, Craig, MD, PCUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 Jun 2022 (actual)
- 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.
To compare safety, patient satisfaction, and technical correction between a limited and full facelift, patients meeting strict clinical and safety criteria for both types of facelift will be randomly assigned to have one of these procedures. In the context of this study, a limited facelift is done in the office under local anesthesia, and a full facelift is done in the hospital or ambulatory surgical center with either general anesthesia or intravenous sedation.
Detailed description
While there are previous reports of facelift in an office-based setting without general anesthesia or intravenous sedation, these reports included patient demographic information, medical history, and complication rates only and did not compare their office-based facelift with a full facelift done in the hospital or ambulatory surgical center. Previous reports also included oral sedation for all patients.
The current study will address these gaps in what is known about office-based limited facelifts done with local anesthesia. Finally, the study will also ascertain patient satisfaction at 3 points-at the pre-operative visit, early post-operative visit, and final visit-using selected modules from the validated FACE-Q | Aesthetics survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office-based limited facelift | Experimental | Procedure: Limited facelift, Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline, Other: FACE-Q | Aesthetics - Recovery Early Symptoms, Other: FACE-Q | Aesthetics - Satisfaction with Outcome, Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, NeckPatients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication. |
| Hospital-based full facelift | Active comparator | Procedure: Full facelift, Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline, Other: FACE-Q | Aesthetics - Recovery Early Symptoms, Other: FACE-Q | Aesthetics - Satisfaction with Outcome, Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, NeckPatients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient willing to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital
- Patient willing and able to accept financial responsibilities of undergoing either type of facelift.
- Patient able to provide informed consent
- Between age 40-years-old and 85-years-old
- No history of bleeding disorder
Key exclusion criteria (13 listed)
- Patient refusal to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital
- Patient not willing or not able to accept financial responsibilities of undergoing either type of facelift.
- Patient unable to provide informed consent
- Under age 40-years-old or over 85-years-old
- History of bleeding disorder
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 |
|---|---|---|
| Limited faceliftAlso: Limited dissection SMAS manipulationA limited procedure under local anesthesia that addresses signs of aging in the lower face and neck | Procedure or surgery | Office-based limited facelift |
| Full faceliftAlso: SMAS manipulationA full face and neck lift that addresses signs of aging in the face and neck | Procedure or surgery | Hospital-based full facelift |
| FACE-Q | Aesthetics - Satisfaction With Lower Face and JawlineCompleted by patients. The FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline is a 5-item questionnaire. Each item is rated 1-4, with 1 being "Very Dissatisfied" and 4 being "Very Satisfied". Lower scores suggest the person may be less pleased with the appearance of their lower face and jawline. | Other | Hospital-based full facelift, Office-based limited facelift |
| FACE-Q | Aesthetics - Recovery Early SymptomsCompleted by patients. The FACE-Q | Aesthetics - Recovery Early Symptoms is a 17-item questionnaire. Each item is rated 1-4, with 1 being "Not at all" and 4 being "Extremely". Lower scores suggest the person may be experiencing fewer symptoms early in their recovery following an aesthetic facial procedure. | Other | Hospital-based full facelift, Office-based limited facelift |
| FACE-Q | Aesthetics - Satisfaction with OutcomeCompleted by patients. The FACE-Q | Aesthetics - Satisfaction with Outcome is a 6-item questionnaire. Each item is rated 1-4, with 1 being "Definitely disagree" and 4 being "Definitely agree". Lower scores suggest the person may be less pleased with their final appearance following surgery and the decision to have an aesthetic facial procedure. | Other | Hospital-based full facelift, Office-based limited facelift |
| FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, NeckCompleted by patients. The FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck is a 15-item questionnaire. Each item is rated 1-3, with 1 being "Not at all" and 3 being "A lot". Lower scores suggest the person may be experiencing fewer chronic symptoms following an aesthetic facial procedure. | Other | Hospital-based full facelift, Office-based limited facelift |
Primary outcome
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
Time frame: 1 hour following surgery and 2 weeks following surgery
Post-operative adverse effects may be acute, such as hematoma or infection, or they may become apparent later, such as nerve injury. Not all post-operative adverse effects will require treatment, such as mild pain, swelling, or bruising.
Difference in post-operative aesthetic correction rating between groups
Time frame: an average of 1 year following surgery
Post-operative aesthetic correction rating is completed based on comparison with pre-operative photographs. Ratings possible are 1 (no improvement) to 5 (excellent).
1 secondary outcome
Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit
Time frame: an average of 30 days before surgery and again an average of 1 year following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be available to other researchers.
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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.
Craig R Dufresne, MD principal investigator
Office of Dr Craig R Dufresne, MD, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited facelift, Full facelift and FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline in people with Skin Aging and Facial Asymmetry, run by Dufresne, Craig, MD, PC 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 13 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikaela I Poling, BA (7032073065, research@duplastics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects (time frame: 1 hour following surgery and 2 weeks following surgery). The study lists 2 primary outcomes in all. 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 19 Jul 2022.