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Cryolipolysis and Subcision for Treatment of Cellulite

Primary Purpose

Cellulite

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cryolipolysis

Subcision

Control

About this trial

This is an interventional treatment trial for Cellulite focused on measuring Cellulite, Cryolipolysis, Zeltiq, Subcision

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
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:

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 hemoglobinuria, or cold urticaria.
Subjects who have active skin disease or skin infection in treatment area.
Subjects who are allergic to lidocaine or prilocaine.
Subjects who are allergic to both cephalexin (and 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 3

Arm Type

Experimental

Active Comparator

Arm Label

cryolipolysis

subcision

Control

Arm Description

Areas with cellulite that had no treatment performed were considered the control arm.

Outcomes

Primary Outcome Measures

Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.

Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.

Secondary Outcome Measures

Full Information

NCT ID

NCT01209767

First Posted

September 24, 2010

Last Updated

December 1, 2021

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01209767

Brief Title

Cryolipolysis and Subcision for Treatment of Cellulite

Official Title

Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.

6. Conditions and Keywords

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

Cellulite

Keywords

Cellulite, Cryolipolysis, Zeltiq, Subcision

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cryolipolysis

Arm Type

Experimental

Arm Title

subcision

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Areas with cellulite that had no treatment performed were considered the control arm.

Intervention Type

Device

Intervention Name(s)

cryolipolysis

Intervention Description

During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite

Intervention Type

Procedure

Intervention Name(s)

Subcision

Intervention Description

Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.

Intervention Type

Other

Intervention Name(s)

Control

Other Intervention Name(s)

No intervention in this group

Primary Outcome Measure Information:

Title

Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks. 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: 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 hemoglobinuria, or cold urticaria. Subjects who have active skin disease or skin infection in treatment area. Subjects who are allergic to lidocaine or prilocaine. Subjects who are allergic to both cephalexin (and 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

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Cryolipolysis and Subcision for Treatment of Cellulite

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