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CoolCurve vs. ATX-101 for Upper Back Fat
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Subjects who are unable to understand the protocol or give informed consent
Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 90
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether cryolipolysis or ATX-101 is more effective for treating upper back fat. If you live in the Chicago area and meet the criteria, you may be eligible to participate.
Who is the study for?
This trial is for adults over 18 in good health with mild to moderate upper back fat, living in the Chicago area. They must understand and consent to participate. Excluded are those with cold-induced diseases, scar issues, pregnancy, breastfeeding, neurological disorders affecting cooperation or understanding of the protocol, and anyone on antiplatelet/anticoagulant therapy or with coagulation disorders.
What is being tested?
The study compares cryolipolysis (CoolCurve) and ATX-101 (deoxycholic acid) for reducing upper back fat. Participants will have one side of their back treated with CoolCurve and the other side with ATX-101 randomly. The goal is to see which treatment is more effective.
What are the potential side effects?
Possible side effects may include reactions at the treatment site such as redness, swelling, pain or tenderness; these are common after both cryolipolysis and injections like ATX-101.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I understand the study and can give my consent.
Select...
I am currently taking medication to prevent blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in fat measurements from baseline to Day 90.
Side effects data
From 2015 Phase 3 trial • 55 Patients • NCT0212313471%
Injection site pain
71%
Injection site bruising
61%
Injection site swelling
50%
Injection site anaesthesia
29%
Injection site nodule
18%
Injection site oedema
14%
Injection site induration
14%
Injection site erythema
7%
Skin tightness
7%
Dysphonia
7%
Pain in jaw
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ATX-101 (Deoxycholic Acid) Injection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Deoxycholic AcidExperimental Treatment1 Intervention
Group II: CyrolipolysisActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATX-101
2008
Completed Phase 3
~330
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,481 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,546 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.