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Active, not recruitingNCT02427698Updated Jul 1, 2026

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

An interventional study of cyrolipolysis (CoolSculpting device) and subcision in Cellulite, sponsored by Northwestern University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

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.

02

Conditions studied

  • Cellulite

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    cyrolipolysis

    Procedure: cyrolipolysis (CoolSculpting device)

  • Active comparator
    cryolipolysis plus subcision

    Procedure: cyrolipolysis (CoolSculpting device) · Procedure: subcision

Interventions

  • Procedurecyrolipolysis (CoolSculpting device)

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

  • Proceduresubcision

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

05

What researchers measure

Primary outcomes

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

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

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

06

Study locations

1 site
  • Northwestern University Feinberg School of Medicine, Department of Dermatology
    Chicago, Illinois 60611, United States
07

Registry details

Key details

Study ID
NCT02427698
Lead sponsor
Northwestern University
Collaborators
Zeltiq Aesthetics
Responsible party
Murad Alam (Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University) — Principal investigator
First posted
Apr 28, 2015
Start date
Aug 2015
Primary completion
May 20, 2026
Completion
Dec 2028 (estimated)
Last update
Jul 1, 2026

Study contacts

Murad Alam, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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