This trial is active, not recruiting.

Condition cellulite
Treatments cyrolipolysis (coolsculpting device), subcision
Sponsor Northwestern University
Collaborator Zeltiq Aesthetics
Start date August 2015
End date December 2016
Trial size 15 participants
Trial identifier NCT02427698, STU200346


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
cyrolipolysis (coolsculpting device)
Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
(Active Comparator)
cyrolipolysis (coolsculpting device)
Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.

Primary Outcomes

Live rating by a blinded dermatologist using cellulite severity scale
time frame: Change from Baseline in cellulite severity scale at 3 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial
Principal investigator Murad Alam, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Northwestern University.