Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Cellulite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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cyrolipolysis

Group Type ACTIVE_COMPARATOR

cyrolipolysis (CoolSculpting device)

Intervention Type PROCEDURE

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

cryolipolysis plus subcision

Group Type ACTIVE_COMPARATOR

cyrolipolysis (CoolSculpting device)

Intervention Type PROCEDURE

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

subcision

Intervention Type PROCEDURE

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

Interventions

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cyrolipolysis (CoolSculpting device)

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

Intervention Type PROCEDURE

subcision

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes