Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2010-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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cryolipolysis
cryolipolysis
During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
subcision
Subcision
Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Control
Areas with cellulite that had no treatment performed were considered the control arm.
Control
Interventions
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cryolipolysis
During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
Subcision
Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU34401
Identifier Type: -
Identifier Source: org_study_id