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

NCT03284034 — Not applicable, Terminated, 8 participants, Northwestern University

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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.

Registry	NCT03284034
Status	Terminated - Unable to enroll participants for analysis.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	8 (Actual)
Sponsor	Northwestern University (Other)
Conditions	Upper Back Fat
Interventions	CoolCurve, ATX-101 (Device, drug)
Dates	start 2017-11-27, primary completion 2020-06-08, completion 2020-06-08, first posted 2017-09-15, last updated 2025-05-06
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cyrolipolysis	Active comparator	Device: CoolCurve
Deoxycholic Acid	Experimental	Drug: ATX-101

CoolCurve (Device), also known as CoolSculpt: 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.
ATX-101 (Drug), also known as Kybella: 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.

+Outcome measures

Primary outcomes

Change in fat measurements from baseline to Day 90. [Baseline and Day 90]: Subcutaneous fat measurement will be performed using an ultrasound.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Males or females ≥ 18 years old
2. Subjects are in good health as judged by the investigator.
3. Subjects with mild to moderate upper back fat.
4. 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:

1. History of hypertrophic scars or keloids
2. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder
3. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
4. Pregnant or breast feeding
5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
6. Subjects who are unable to understand the protocol or give informed consent.

+Locations (1)

Facility	City	Country	Status
Northwestern University Department of Dermatology	Chicago, Illinois	United States

+Investigators

Murad Alam, MD, Principal investigator, Northwestern University

My Notes

Public

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