CoolCurve vs. ATX-101 for Upper Back Fat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Hypertrophic scars, Cold-induced disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to reduce upper back fat: cryolipolysis, which uses cold to break down fat, and ATX-101, an injectable that dissolves fat cells. The study aims to determine which method is more effective by treating one side of the back with cryolipolysis (also known as CoolCurve) and the other with ATX-101. It is ideal for healthy adults with mild to moderate upper back fat who live in the Chicago area. Participants must understand and consent to the study's procedures. As an unphased trial, this study offers participants the chance to contribute to innovative research and potentially benefit from cutting-edge treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking antiplatelet or anticoagulant medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ATX-101, also known as deoxycholic acid, safely reduces fat under the chin. Studies have found it effective, with generally manageable side effects. The FDA has approved it for this use, confirming its safety for this specific purpose.

Similarly, studies have shown that cryolipolysis, also known as CoolCurve, safely reduces fat in certain body areas. Complications are rare and treatable if they occur. Research indicates that it is effective and generally well-received by users.

Both treatments have been studied for their effects on reducing body fat and have been shown to be safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to tackle upper back fat. Unlike traditional methods like liposuction, which is invasive, or CoolSculpting, which uses cryolipolysis to freeze fat cells, CoolCurve and ATX-101 (deoxycholic acid) present novel approaches. CoolCurve employs a targeted cooling process to reduce fat without surgery, making it less invasive. ATX-101, on the other hand, uses deoxycholic acid to break down fat cells through injection, offering a non-surgical and precise method. These innovative treatments have the potential to provide effective and less invasive options for contouring the upper back.

What evidence suggests that this trial's treatments could be effective for upper back fat?

This trial will compare two treatments for reducing upper back fat: ATX-101 and CoolCurve. Research has shown that ATX-101, also known as deoxycholic acid, can effectively reduce fat in specific areas. In earlier studies, ATX-101 reduced fat under the chin and offered a less invasive option compared to liposuction. Patients noticed significant fat reduction and maintained these results over time.

Meanwhile, studies have demonstrated that cryolipolysis, the method used by CoolCurve, safely reduces fat by freezing it. This treatment resulted in a 20-27% fat reduction in treated areas after just one session. Many participants experienced fat loss and were satisfied with the results, with few complications reported. Both options in this trial show promising results for reducing fat in the upper back area. ^{1 4 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good health with mild to moderate upper back fat, living in the Chicago area. They must understand and consent to participate. Excluded are those with cold-induced diseases, scar issues, pregnancy, breastfeeding, neurological disorders affecting cooperation or understanding of the protocol, and anyone on antiplatelet/anticoagulant therapy or with coagulation disorders.

Inclusion Criteria

I understand the study and agree to participate.

I have mild to moderate fat on my upper back.

Subjects are in good health as judged by the investigator

Exclusion Criteria

I am currently taking medication to prevent blood clots.

I understand the study and can give my consent.

Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryolipolysis on one side and ATX-101 on the contralateral side of the upper back fat

12 weeks

Multiple visits for treatment application

Follow-up

Participants are monitored for changes in fat measurements and safety after treatment

4 weeks

1 visit (in-person) for final assessment

What Are the Treatments Tested in This Trial?

Interventions

• ATX-101
• CoolCurve

Trial Overview The study compares cryolipolysis (CoolCurve) and ATX-101 (deoxycholic acid) for reducing upper back fat. Participants will have one side of their back treated with CoolCurve and the other side with ATX-101 randomly. The goal is to see which treatment is more effective.

How Is the Trial Designed?

Group I: Deoxycholic Acid Experimental Treatment 1 Intervention

Group II: Cyrolipolysis Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4232897/

Reduction of unwanted submental fat with ATX-101 ... In this double-blind, placebo-controlled, phase III study, 363 patients with moderate/severe SMF were randomized to receive ATX-101 (1 or 2 mg cm−2) or placebo ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4263247/

results from a phase III, randomized, placebo-controlled study ATX-101 treatment offers long-term durability of submental fat reduction ... reduction of submental fat: pharmacokinetic and safety findings from a phase I trial.

3. journals.lww.com journals.lww.com/prsgo/fulltext/2021/07000/best_clinical_practices_with_atx_101_for_submental.12.aspx

Best Clinical Practices with ATX-101 for Submental Fat... Submental fat can be reduced with ATX-101 (deoxycholic acid injection), a customizable and minimally invasive alternative to liposuction.

4. cochranelibrary.com cochranelibrary.com/content;jsessionid=FAEF37AC3025AA03BEFB65F989C0538B?templateType=related&urlTitle=%2Fcentral%2Fdoi%2F10.1002%2Fcentral%2FCN-00982224&doi=10.1002%2Fcentral%2FCN-00982224&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Reduction of unwanted submental fat with ATX-101 ... ... Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/17512433.2021.1884070

Efficacy and safety of injectable deoxycholic acid for ... DOC is effective and safe for SMF reduction with no differences between doses of 1 and 2 mg/cm 2.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570630/

Efficacy, safety, and potential industry bias in using ... Deoxycholic acid is effective in submental fat reduction for both clinician and patient-related outcomes. Well-tolerated side-effects were observed in ...

7. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2019/12000/novel_expanded_safe_zone_for_reduction_of.14.aspx

Novel Expanded Safe Zone for Reduction of Submental... ATX-101 (deoxycholic acid injection; Kybella) provides an approved nonsurgical treatment option for reduction of submental fullness caused by submental fat.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000MedR.pdf

206333Orig1s000 - accessdata.fda.gov Two adequate and controlled phase 3 trials demonstrated the efficacy and safety of ATX-101 for adult patients 18-65 years old with moderate to ...