Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Study Overview
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Brief Summary
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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.

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

Conditions
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Cellulite

Intervention / Treatment
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* Procedure: cyrolipolysis (CoolSculpting device)
* Procedure: subcision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cyrolipolysis<br> | Procedure: cyrolipolysis (CoolSculpting device)<br>* Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.<br>|
| Active Comparator: cryolipolysis plus subcision<br> | Procedure: cyrolipolysis (CoolSculpting device)<br>* Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.<br>Procedure: subcision<br>* The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline in cellulite severity scale at 3 months |