Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
This trial is active, not recruiting.
|Treatments||cyrolipolysis (coolsculpting device), subcision|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Live rating by a blinded dermatologist using cellulite severity scale
time frame: Change from Baseline in cellulite severity scale at 3 months
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.
|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|
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