Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.

Conditions
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Upper Back Fat

Intervention / Treatment
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* Device: CoolCurve
* Drug: ATX-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥ 18 years old Subjects are in good health as judged by the investigator. Subjects with mild to moderate upper back fat. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. Exclusion Criteria: History of hypertrophic scars or keloids Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria. Pregnant or breast feeding Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. Subjects who are unable to understand the protocol or give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyrolipolysis<br> | Device: CoolCurve<br>* The right and left sides of the upper back fat will be randomly assigned to receive Cryolypolysis (CoolCurve + Advantage applicator) 35 minutes session, 3 sessions 30 days apart.<br>* Other names: CoolSculpt;|
| Experimental: Deoxycholic Acid<br> | Drug: ATX-101<br>* The right and left sides of the upper back fat will be randomly assigned to receive The right and left sides of the upper back fat will be randomly assigned to receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.<br>* Other names: Kybella;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fat measurements from baseline to Day 90. | Subcutaneous fat measurement will be performed using an ultrasound. | Baseline and Day 90 |