8 Participants Needed

CoolCurve vs. ATX-101 for Upper Back Fat

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

Trial Summary

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.

Research Team

Murad Alam, MD | Northwestern Medicine

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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 am 18 years old or older.
Subjects are in good health as judged by the investigator
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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
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Treatment Details

Interventions

  • ATX-101
  • CoolCurve
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Deoxycholic AcidExperimental Treatment1 Intervention
Group II: CyrolipolysisActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+