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NCT Number: NCT02427698

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cellulite Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
  • 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).
  • 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

  • Subjects who are pregnant or lactating.
  • Subjects who are unable to understand the protocol or to give informed consent.
  • Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
  • Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
  • Subjects who have active skin disease or skin infection in the treatment area.
  • Subjects who are allergic to lidocaine or prilocaine.
  • Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
  • Subjects who have history of abnormal scarring.

Treatment and study plan

cyrolipolysis (CoolSculpting device)

Procedure

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

subcision

Procedure

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

Primary outcomes

  1. Live rating by a blinded dermatologist using cellulite severity scale

    Time frame: Change from Baseline in cellulite severity scale at 3 months

    The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Zeltiq Aesthetics

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2028
First posted
Apr 28, 2015
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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