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

NCT03284034 | Terminated DMC

• 1 other identifier: STU00205070
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Back Fat

Outcome Measures

Primary Outcomes (1)

• Change in fat measurements from baseline to Day 90.

  Subcutaneous fat measurement will be performed using an ultrasound.

  Baseline and Day 90

Study Arms (2)

Cyrolipolysis

ACTIVE COMPARATOR

Device: CoolCurve

Deoxycholic Acid

EXPERIMENTAL

Drug: ATX-101

Interventions

CoolCurve DEVICE

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.

Also known as: CoolSculpt

Cyrolipolysis

ATX-101 DRUG

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.

Also known as: Kybella

Deoxycholic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: November 27, 2017
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)