Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- CoolCurve
- Conditions
- Upper Back Fat
- Sponsor
- Northwestern University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in fat measurements from baseline to Day 90.
- Status
- Terminated
- Last Updated
- 12 months ago
Overview
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.
Investigators
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University
Eligibility Criteria
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.
Arms & Interventions
Cyrolipolysis
Intervention: CoolCurve
Deoxycholic Acid
Intervention: ATX-101
Outcomes
Primary Outcomes
Change in fat measurements from baseline to Day 90.
Time Frame: Baseline and Day 90
Subcutaneous fat measurement will be performed using an ultrasound.