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Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

NCT02427698 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-31

No results posted yet for this study

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

  • Cellulite

Interventions

PROCEDURE

cyrolipolysis (CoolSculpting device)

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

PROCEDURE

subcision

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

Sponsors & Collaborators

Principal Investigators

  • Murad Alam, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427698 on ClinicalTrials.gov