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Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Primary Purpose

Cellulite

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cyrolipolysis (CoolSculpting device)

subcision

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
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:

Subjects who are pregnant or lactating.
Subjects who are unable to understand the protocol or to give informed consent.
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.
Subjects who have active skin disease or skin infection in the treatment area.
Subjects who are allergic to lidocaine or prilocaine.
Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
Subjects who have history of abnormal scarring.

Sites / Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

cyrolipolysis

cryolipolysis plus subcision

Arm Description

Outcomes

Primary Outcome Measures

Live rating by a blinded dermatologist using cellulite severity scale

The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.

Secondary Outcome Measures

Full Information

NCT ID

NCT02427698

First Posted

April 13, 2015

Last Updated

February 17, 2023

Sponsor

Northwestern University

Collaborators

Zeltiq Aesthetics

1. Study Identification

Unique Protocol Identification Number

NCT02427698

Brief Title

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Official Title

Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2015 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Zeltiq Aesthetics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cellulite

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cyrolipolysis

Arm Type

Active Comparator

Arm Title

cryolipolysis plus subcision

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

cyrolipolysis (CoolSculpting device)

Intervention Description

Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.

Intervention Type

Procedure

Intervention Name(s)

subcision

Intervention Description

The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.

Primary Outcome Measure Information:

Title

Live rating by a blinded dermatologist using cellulite severity scale

Description

The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.

Time Frame

Change from Baseline in cellulite severity scale at 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs. All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7). 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: Subjects who are pregnant or lactating. Subjects who are unable to understand the protocol or to give informed consent. 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. Subjects who have active skin disease or skin infection in the treatment area. Subjects who are allergic to lidocaine or prilocaine. Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic). Subjects who have history of abnormal scarring.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine, Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

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