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…
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
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
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 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
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
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
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 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
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
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=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=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=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
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
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 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
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=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…
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=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…
Phase 3 N=55 Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
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…
Phase 3 N=224 Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Submental Fat · Healthy
Primary: Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both…
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=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=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=84 Patient Experience Study of Deoxycholic Acid Injection
Moderate or Severe Submental Fullness
Primary: Change From Baseline in Pain Visual Analog Scale Scores — 0.0; 0.0; 0.0; 0.0 units on a scale — p=0.6803
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