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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyrolipolysis | Active Comparator |
| |
| Deoxycholic Acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fat measurements from baseline to Day 90. | Subcutaneous fat measurement will be performed using an ultrasound. | Baseline and Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 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. |
|
|
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |