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Procedure

Limited facelift for Skin Aging (COAL2 Trial)

N/A
Recruiting
Led By Craig R Dufresne, MD
Research Sponsored by Dufresne, Craig, MD, PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 1 year following surgery
Awards & highlights

Summary

This trial will compare the safety, patient satisfaction, and technical correction of a limited facelift done under local anesthesia with a full facelift done under general anesthesia or intravenous sedation.

Eligible Conditions
  • Age-Related Issues
  • Skin Aging
  • Facial Asymmetry

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 1 year following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 1 year following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
Difference in post-operative aesthetic correction rating between groups
Secondary outcome measures
Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit
Other outcome measures
Difference of "FACE-Q - Recovery Early Symptoms" scores between groups
Difference of "FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck" scores between groups
Difference of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" baseline and last post-operative visit scores between groups
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Office-based limited faceliftExperimental Treatment5 Interventions
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Group II: Hospital-based full faceliftActive Control5 Interventions
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.

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Who is running the clinical trial?

Dufresne, Craig, MD, PCLead Sponsor
3 Previous Clinical Trials
60 Total Patients Enrolled
Craig R Dufresne, MDPrincipal InvestigatorOffice of Dr Craig R Dufresne, MD, PC
3 Previous Clinical Trials
60 Total Patients Enrolled
~33 spots leftby Jul 2025
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