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

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. The treatment sites are the right and left upper back fat areas. The right and left sides of the upper back fat will be randomly assigned (1:1) to receive cryolipolysis, while the contralateral side will receive ATX-101. This study was a pilot study designed to determine feasibility of this procedure.

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.

Subjects are in good health as judged by the investigator

I have mild to moderate fat on my upper back.

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+