Clinical trials: Submental Fat
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
An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.
This is a Phase 2, open label study that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period.
- Trial name
- NCT05466448
- Testing
- RZL-012
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
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
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
Submental Fat
A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.
Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012.
- Trial name
- NCT04086823
- Testing
- RZL-012
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Raziel Therapeutics Ltd.
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.
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
Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).
- Trial name
- NCT01426373
- Testing
- Deoxycholic acid injection
- Where
- 18 sites in United States
- Volunteers
- 165 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
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.
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
- NCT01305577
- Testing
- Deoxycholic acid injection
- Where
- 30 sites in Belgium, France and 3 more
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
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
- NCT01546142
- Testing
- Deoxycholic acid injection
- Where
- 35 sites in United States, Canada
- Volunteers
- 516 people, healthy volunteers welcome
- Sponsor
- Kythera Biopharmaceuticals
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
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
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.
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
Body Fat Disorder
Pilot Study on the Submental Area
The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.
- Trial name
- NCT01859091
- Testing
- The Zeltiq System
- Where
- United States
- Volunteers
- 14 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
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