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Active Not RecruitingNCT02427698

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcyrolipolysis (CoolSculpting device)Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
PROCEDUREsubcisionThe skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.

Timeline

Start date
2015-08-01
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2015-04-28
Last updated
2025-01-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02427698. Inclusion in this directory is not an endorsement.