Clinical trials: Submental Fat
Body Fat Disorder
Fat Reduction in the Submandibular/Submental Area
The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.
- Trial name
- NCT02700165
- Testing
- The ZELTIQ CoolSculpting System
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Skin Laxity, Lipodystrophy
CONFORM: Rotational Fractional Resection for Submental Contouring
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.
- Trial name
- NCT03407313
- Testing
- Rotational fractional resection (1.5mm diameter device)
- Where
- 6 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Recros Medica, Inc.
Submental Fat, Healthy
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
- Trial name
- NCT02163902
- Testing
- ATX-101
- Where
- 15 sites in United States, Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Moderate or Severe Submental Fullness
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
- Trial name
- NCT01032889
- Testing
- Deoxycholic acid injection
- Where
- 10 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Moderate to Severe Convexity of Submental Fat, Safety
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.
- Conditions
- Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
- Trial name
- NCT02123134
- Testing
- ATX-101
- Where
- 6 sites in United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Submental Fat
Efficacy and Safety of RZL-012 on Submental Fat Reduction
A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo…
- Trial name
- NCT04867434
- Testing
- RZL-012
- Where
- United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
Moderate or Severe Submental Fullness
Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
- Trial name
- REFINE-1 (NCT01542034)
- Testing
- Deoxycholic acid injection
- Where
- 36 sites in United States, Canada
- Volunteers
- 506 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Mild to Moderate Skin Laxity on Cheek, Mild to Moderate Skin Laxity on Upper Neck
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™…
- Conditions
- Mild to Moderate Skin Laxity on Cheek, Mild to Moderate Skin Laxity on Upper Neck, Mild to Moderate Subcutaneous Fat on Cheek, Mild to Moderate Subcutaneous Fat on Upper Neck
- Trial name
- NCT01368835
- Testing
- Ulthera treatment
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Ulthera, Inc
Submental Fullness
Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat
Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat.
- Trial name
- NCT06509438
- Testing
- Embella (Deoxycholic acid, produced by Espad Pharmed Co.)
- Where
- Iran
- Volunteers
- 20 people
- Sponsor
- Espad Pharmed
Non-invasive Fat Reduction
CoolSculpting® Elite for Non-Invasive Fat Reduction
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area…
- Trial name
- NCT04897867
- Testing
- CoolSculpting® Elite System with CoolSculpting® Elite applicators
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Allergan
Submental Fat
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
- Trial name
- NCT05476679
- Testing
- RZL-012, RZL-012+Lidacaine injection prior treatment, RZL-012+Medrol
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
Adiposity
Kybella With Triamcinolone
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of…
- Trial name
- NCT03361176
- Testing
- Injectable sodium deoxycholate, Injectable sodium deoxycholate with Triamcinolone acetate
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
Moderate or Severe Submental Fullness
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
- Trial name
- NCT00618618
- Testing
- Deoxycholic Acid Injection
- Where
- 7 sites in Australia, Canada and 1 more
- Volunteers
- 73 people
- Sponsor
- Kythera Biopharmaceuticals
Body Fat Disorder
CoolSculpting and RF for the Submental
The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.
- Trial name
- CRT (NCT03873779)
- Testing
- The ZELTIQ System
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Body Fat Disorder
Subcutaneous Fat Reduction in the Submental Area
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis. Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat.
- Trial name
- NCT02298322
- Testing
- CoolSculpting System
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Weight Loss
An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat
The purpose of this clinical study is to determine the effectiveness of the Erchonia® CFL (manufactured by Erchonia Corporation (the Company), in providing noninvasive fat reduction in the submental area.
- Trial name
- NCT05954065
- Testing
- Erchonia CFL Laser
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Erchonia Corporation
Moderate to Severe Convexity of Submental Fat, Safety
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and…
- Conditions
- Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
- Trial name
- NCT02035267
- Testing
- Deoxycholic Acid
- Where
- 8 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Submental Fat, Healthy
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
- Trial name
- NCT02159729
- Testing
- ATX-101 (1 mg/cm^2), ATX-101 (2 mg/cm^2), ATX-101 (4 mg/cm^2)
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
Body Fat Disorder
Submental Study (Sequential Treatment Approach)
Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.
- Trial name
- CMK (NCT03510598)
- Testing
- The ZELTIQ CoolSculpting System, Kybella 20 MG in 2 ML Injection
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Moderate or Severe Submental Fullness
Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
- Trial name
- NCT01294644
- Testing
- Deoxycholic acid injection
- Where
- 29 sites in Belgium, France and 4 more
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals