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

Not Applicable

Active, not recruiting

• Conditions: Upper Back Fat
• Interventions: Device: CoolCurve; Drug: ATX-101

• Registration Number: NCT03284034
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-15
• Study Start: 2017-11-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyrolipolysis	CoolCurve	-
Deoxycholic Acid	ATX-101	-

Primary Outcome Measures

Name	Time	Method
Change in fat measurements from baseline to Day 90.	Baseline and Day 90	Subcutaneous fat measurement will be performed using an ultrasound.

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States