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

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03284034
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
61.1
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.
Actual Study Start Date :
Nov 27, 2017
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cyrolipolysis

Device: CoolCurve
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.
Other Names:
  • CoolSculpt

    		•
    Experimental: Deoxycholic Acid

    Drug: ATX-101
    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.
    Other Names:
  • Kybella

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in fat measurements from baseline to Day 90. [Baseline and Day 90]

      Subcutaneous fat measurement will be performed using an ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Department of Dermatology Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Murad Alam, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT03284034
    Other Study ID Numbers:
    • STU00205070
    First Posted:
    Sep 15, 2017
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Deoxycholic Acid

    Study Results

    No Results Posted as of Mar 4, 2022