Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite (NCT02427698) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
United States15 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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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.
What they're measuring
1
Live rating by a blinded dermatologist using cellulite severity scale
Timeframe: Change from Baseline in cellulite severity scale at 3 months