N/A N=60 Subcutaneous Fat Reduction in the Submental Area
Body Fat Disorder
Primary: Safety of CoolScupting in the Submental Area — 4 incidence of device- and/or procedure AE
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=16 Submental Study (Sequential Treatment Approach)
Body Fat Disorder
Primary: The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When…
Phase 3 N=93 Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
Moderate to Severe Convexity of Submental Fat · Safety · Efficacy
Primary: Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating…
N/A N=14 Fat Reduction in the Submandibular/Submental Area
Body Fat Disorder
Primary: Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers — 11 photos
N/A N=68 CONFORM: Rotational Fractional Resection for Submental Contouring
Skin Laxity · Lipodystrophy
Primary: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 — 49 Participants
Phase 4 N=58 Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Contour
Primary: Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the…
N/A N=15 Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Skin Laxity
Primary: Percent Change From Baseline of Soft Tissue Surface Area — -0.18; -017 percent change
Phase 2 N=129 Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Moderate or Severe Submental Fullness
Primary: Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores — -0.7; -0.8; -0.4 units on a scale — p=0.052
Phase 3 N=165 Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area
Moderate or Severe Submental Fullness
Primary: Number of Participants With Adverse Events (AEs) — 160; 7; 11; 15 participants
N/A N=1,029 Condition of Submental Fullness and Treatment Outcomes Registry
Submental Fullness
Primary: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 13.2; 8.7; 20.0; 5.2 percentage of participants
Phase 3 N=360 Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Moderate or Severe Submental Fullness
Primary: Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response — 58.3; 62.3; 34.5 percentage of participants — p=<0.001
N/A N=20 Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
Submental Fullness
Primary: Number of Participants With A Minimum of One Grade Improvement in the Standard Submental Fat (SMF) Assessment Grading — 15; 10 Participants
Phase 3 N=363 Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Moderate or Severe Submental Fullness
Primary: Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response — 59.2; 65.3; 23.0 percentage of participants — p=<0.001
Phase 2 N=73 Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Moderate or Severe Submental Fullness
Primary: Number of Participants With Adverse Events — 24; 13; 20; 14 participants
Phase 3 N=506 Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
Moderate or Severe Submental Fullness
Primary: Percentage of Participants Who Achieved a Composite 1-grade Response — 70.0; 18.6 percentage of participants — p=<0.001
N/A N=2 The PREFORM Study: Rotational Fractional Resection for Submental Contouring
Skin Laxity · Lipodystrophy
Primary: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale — 2 Participants
Phase 3 N=516 Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
Moderate or Severe Submental Fullness
Primary: Percentage of Participants Who Achieved a Composite 1-grade Response — 66.5; 22.2 percentage of participants — p=<0.001
Phase 2 N=85 Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Moderate or Severe Submental Fullness
Primary: Number of Participants With Adverse Events — 20; 19; 22; 21 participants
N/A N=8 CoolSculpting and RF for the Submental
Body Fat Disorder
Primary: Number of Participants With Unanticipated Adverse Device Effects (UADEs) — 0 Participants
N/A N=14 Pilot Study on the Submental Area
Body Fat Disorder
Primary: Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) — 0; 0 participants
N/A N=60 Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Mild to Moderate Skin Laxity Under the Chin · Mild to Moderate Skin Laxity on Neck
Primary: Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment — -14.4; -7.9; -22.3 square…
N/A N=72 Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
Skin Laxity
Primary: Tissue Lift at the Submental Area Measuring >/= 20 mm2 — 56.9 percentage of participants — p=0.05
N/A N=31 An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat
Weight Loss
Primary: Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. — 26 Participants
N/A N=15 Cryolipolysis for Jawline Contouring
Body Fat Disorder
Primary: Number of Participants With Unanticipated Adverse Device Effects (UADE) — 0 Participants with UADE reported
N/A N=32 Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Skin Laxity
Primary: Improvement in Overall Lifting and Tightening of Skin — 48 percentage of participants improved
Phase 2 N=151 Efficacy and Safety of RZL-012 on Submental Fat Reduction
Submental Fat
Primary: Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84 — 43; 39; 27 participants
N/A N=25 Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
Body Fat Disorder
Primary: Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. — 0; 0 UADEs
Phase 2 N=15 An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.
Submental Fat
Primary: Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL) — 487.7; 473.3 concentration (ng/ml)
N/A N=148 Restylane Defyne for Correction of Chin Retrusion
Chin Retrusion
Primary: Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline…
N/A N=30 Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat
Flank Fat
Primary: The Number of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at…