Status:

COMPLETED

Cryolipolysis and Subcision for Treatment of Cellulite

Lead Sponsor:

Northwestern University

Conditions:

Cellulite

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cool...

Eligibility Criteria

Inclusion

  • Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
  • 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

  • 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 hemoglobinuria, or cold urticaria.
  • Subjects who have active skin disease or skin infection in treatment area.
  • Subjects who are allergic to lidocaine or prilocaine.
  • Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
  • Subjects who have history of abnormal scarring.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2011

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT01209767

Start Date

October 1 2010

End Date

September 1 2011

Last Update

December 3 2021

Active Locations (1)

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1

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States, 60611