Cyrolipolysis Vs Cyrolipolysis and Subcision for Cellulite

Northwestern University

Status: Active, not recruiting

Conditions: Cellulite

Treatments: Procedure: subcision; Procedure: cyrolipolysis (CoolSculpting device)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02427698

STU200346

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
2. 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).
3. 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. Subjects who are pregnant or lactating.
2. Subjects who are unable to understand the protocol or to give informed consent.
3. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
4. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
5. Subjects who have active skin disease or skin infection in the treatment area.
6. Subjects who are allergic to lidocaine or prilocaine.
7. Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
8. Subjects who have history of abnormal scarring.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

cyrolipolysis

Active Comparator group

Treatment:

Procedure: cyrolipolysis (CoolSculpting device)

cryolipolysis plus subcision

Active Comparator group

Treatment:

Procedure: cyrolipolysis (CoolSculpting device)

Procedure: subcision